Notificaciones De Seguridad De Campo acerca de Triathlon PKR Unicondylar Femoral Component Cemented – Implant, Scorpio Waffle Total Stabilized Femoral Component Tip: Left; Right– Implant, Scorpio femoral Component without LFIT and with Pegs Tip: CR Left; CR Right; PS Left; PS Right– Implant

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por HOWMEDICA INTERNATIONAL.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2014-05-09
  • Fecha de publicación del evento
    2014-06-10
  • País del evento
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Notas adicionales en la data
  • Causa
    During the quality control process, the manufacturer noted, for certain lots of "triathlon" femoral and "scorpio" femoral components and restorative wedge enhancers, the incompatibility of the inner packaging with the requirements. specifically, it was found that the force required to open the inner package was less than the force prescribed by internal, validated requirements. the long-term shelf life of a sterile barrier is conditioned by the way the primary packaging is welded, that is, the stability of the sterile barrier depends on the strength with which the packaging is welded. during the quality control process, it was confirmed that the outer packaging of these medical devices was complete or undamaged. by investigation, the manufacturer has determined that the cause of the problem lies in production. the vacuum pressure of the equipment was found to be low because there was a fault on the pressure gauge as well as on the valve. by adjusting the control valve, the cause of the problem has been eliminated. possible patient complications that occur when a sterile barrier is broken are an infection that requires additional medical intervention, as well as delaying surgery if the healthcare provider notices that the packaging is poorly welded, doubts the sterility of the product, and decides to purchase another implantable medical device .

Device

  • Modelo / Serial
    MNH0ND (26-3005L) MNH8XR (26-3005L) MNH3V7 (26-3005L) MNHN0E (26-3005L) MNH6Y5 (26-3005R) MMR8M8 (5096-4615) MMRLYD (5096-4615) MNAYT7 (5096-4615) MMP06K (5096-5015) MNADVA (5096-5015) MMRW0J (5096-5015) MMRAWA (5096-5815) MMR7LT (5096-5815) MNA40L (5096-5815) MMR6HX (5096-5820) MMRLD7 (5096-5825) MMPW05 (5096-6225) MMRM2Y (5096-6225) MMNM07 (5096-6625) KGLX (5512-F-201) JYET (5512-F-201) KFVZ (5512-F-201) JYKX (5512-F-202) KHZL (5512-F-202) KJDN (5512-F-202) KJKY (5512-F-202) IPOP (5512-F-202) KJHI (5512-F-202) KKAE (5512-F-301) KKNB (5512-F-301) JTJA (5512-F-301) KFBY (5512-F-302) KFTZ (5512-F-302) KFXT (5512-F-302) KHAB (5512-F-302) KEYD (5512-F-302) JXXF (5512-F-302) JWGY (5512-F-401) KIED (5512-F-401) JJHT (5512-F-402) JOMB (5512-F-402) KJMO (5512-F-402) KLUP (5512-F-402) JXXM (5512-F-402) KGPE (5512-F-402) IUAJ (5512-F-402) JWPF (5512-F-402) JXMV (5512-F-501) KGKP (5512-F-501) KHWY (5512-F-502) KJBK (5512-F-502) JIML (5512-F-601) JIRX (5512-F-601) KFAS (5512-F-601) KIIY (5512-F-601) KFPI (5512-F-602) KFOS (5512-F-602) KJAG (5512-F-602) KKJW (5512-F-602) KEXE (5512-F-602) JKTF (5512-F-701) JWNL (5512-F-801) JWPY (5512-F-801) JYGID (5515-F-301) JYPJD (5515-F-301) KFWHA (5515-F-301) KIEBA (5515-F-301) KIYUD (5515-F-301) JHZRA (5515-F-301) JITNA (5515-F-301) JKEND (5515-F-301) KGAXD (5515-F-301) IVXZD (5515-F-301) JITND (5515-F-301) JJAFD (5515-F-301) JJNYA (5515-F-301) JJNYD (5515-F-301) JNSRD (5515-F-301) KFXID (5515-F-301) KGXNA (5515-F-301) KIBTA (5515-F-301) KJABD (5515-F-301) KJRID (5515-F-301) JEPOD (5515-F-301) JXBXA (5515-F-301) JYFTD (5515-F-301) JYMTD (5515-F-301) KGJTD (5515-F-301) KIGRD (5515-F-301) KJISD (5515-F-301) IVLVD (5515-F-302) JJSYA (5515-F-302) JJWNA (5515-F-302) JPFDA (5515-F-302) JVYDD (5515-F-302) JWPRA (5515-F-302) JXXZD (5515-F-302) JYBRD (5515-F-302) JYKTA (5515-F-302) JYNIA (5515-F-302) JYNID (5515-F-302) JYUED (5515-F-302) JZDWD (5515-F-302) KFNEA (5515-F-302) KFOBA (5515-F-302) KFOBD (5515-F-302) KFOHD (5515-F-302) KJFXA (5515-F-302) KJFXD (5515-F-302) IPTFD (5515-F-302) IVGVA (5515-F-302) JGIXD (5515-F-302) JIGSD (5515-F-302) JPHRA (5515-F-302) JPIWA (5515-F-302) JSZGD (5515-F-302) JYBRA (5515-F-302) JYMXA (5515-F-302) JZEHD (5515-F-302) JZFDD (5515-F-302) KGMFD (5515-F-302) KHBGA (5515-F-302) KIEXD (5515-F-302) KJBFD (5515-F-302) KJDLD (5515-F-302) KJNPA (5515-F-302) KJNPD (5515-F-302) IOLSD (5515-F-302) IPRVD (5515-F-302) JNVTA (5515-F-302) JOWJD (5515-F-302) JXBKD (5515-F-302) JXOBA (5515-F-302) JYKFD (5515-F-302) KGWGA (5515-F-302) KKJOD (5515-F-302) KGZFA (5515-F-302) IOLTD (5515-F-302) JIYVD (5515-F-302) KFVND (5515-F-302) KGMFA (5515-F-302) JPDRA (5515-F-401) JPIXD (5515-F-401) KABYA (5515-F-401) KFDKD (5515-F-401) KFMLA (5515-F-401) KGAVD (5515-F-401) KHEAA (5515-F-401) KIATA (5515-F-401) KIBVD (5515-F-401) KIFMD (5515-F-401) KJKBD (5515-F-401) JVLND (5515-F-401) JXUDD (5515-F-401) JYMUD (5515-F-401) JZDSA (5515-F-401) KIFOA (5515-F-401) KIIFA (5515-F-401) JYIDD (5515-F-401) KFPNA (5515-F-401) KHKSA (5515-F-401) KHZHA (5515-F-401) JVMTD (5515-F-401) KKFYD (5515-F-401) JIMUD (5515-F-402) JIRZD (5515-F-402) JPFEA (5515-F-402) JPGKD (5515-F-402) KGFLD (5515-F-402) KGRBA (5515-F-402) KKVHA (5515-F-402) JIFRD (5515-F-402) JKESD (5515-F-402) JOUGD (5515-F-402) KLLBD (5515-F-402) KJXDD (5515-F-402) KLBHD (5515-F-402) JYEIA (5515-F-402) KGSHD (5515-F-402) JIGXD (5515-F-402) JLVSA (5515-F-402) JLWTA (5515-F-402) KAJID (5515-F-402) KFSND (5515-F-402) KGYOD (5515-F-402) HWHLA (5515-F-501) IFDEA (5515-F-501) JIAID (5515-F-501) JKGXD (5515-F-501) JOXUA (5515-F-501) JZRRA (5515-F-501) KGIVD (5515-F-501) KGVHD (5515-F-501) KHGPA (5515-F-501) KHXWA (5515-F-501) IEXUA (5515-F-501) JPMVD (5515-F-501) KGKZA (5515-F-501) KGVPD (5515-F-501) KJGBA (5515-F-501) KKHFD (5515-F-501) KGSID (5515-F-501) KHWRD (5515-F-501) JILXA (5515-F-501) JJBFD (5515-F-501) JJTVD (5515-F-501) KFSRA (5515-F-501) KHKAD (5515-F-501) KKHFA (5515-F-501) IKEMD (5515-F-501) KLOSA (5515-F-501) JIVTA (5515-F-502) JJWSA (5515-F-502) JNVJA (5515-F-502) JXTRD (5515-F-502) KFNGD (5515-F-502) KGTMA (5515-F-502) KHGVA (5515-F-502) KHGVD (5515-F-502) KHOFD (5515-F-502) KHWVA (5515-F-502) KJGLD (5515-F-502) KKPKA (5515-F-502) KLSFD (5515-F-502) JKAAD (5515-F-502) JVUAD (5515-F-502) JXFLA (5515-F-502) JZHAD (5515-F-502) JZKTD (5515-F-502) KGYFA (5515-F-502) KHPLA (5515-F-502) KHRTA (5515-F-502) KHWMA (5515-F-502) KIDPA (5515-F-502) KIJDA (5515-F-502) KLBZA (5515-F-502) KLSFA (5515-F-502) JIEZD (5515-F-502) JPFBD (5515-F-502) KGTLA (5515-F-502) KKMDD (5515-F-502) KKOOD (5515-F-502) KKWAA (5515-F-502) KLMBA (5515-F-502) IKRKA (5515-F-502) JIDLA (5515-F-502) JIYYD (5515-F-502) JOPDD (5515-F-502) JXYSA (5515-F-502) JXBYD (5515-F-502) JMBTA (5515-F-601) JXWXA (5515-F-601) KGTDA (5515-F-601) KHJAA (5515-F-601) KHUAA (5515-F-601) KHZYA (5515-F-601) KIGND (5515-F-601) JIUMD (5515-F-601) KFISA (5515-F-601) KHFSA (5515-F-601) KHGNA (5515-F-601) KHSWA (5515-F-601) KHYED (5515-F-601) KABRD (5515-F-601) KFJXA (5515-F-601) KGBVA (5515-F-601) KHLIA (5515-F-601) IPFTA (5515-F-601) JJHZA (5515-F-601) JWFHD (5515-F-601) JWKTA (5515-F-601) KJKOA (5515-F-601) KAGLA (5515-F-601) JIYHD (5515-F-602) JIZOA (5515-F-602) JJBWD (5515-F-602) JJWPD (5515-F-602) JKERA (5515-F-602) JRBRA (5515-F-602) KEZND (5515-F-602) KFKDA (5515-F-602) KGRYD (5515-F-602) KHJTD (5515-F-602) KLKSA (5515-F-602) JKDPD (5515-F-602) JPPKD (5515-F-602) KFTMD (5515-F-602) KGNPD (5515-F-602) JPSXD (5515-F-602) KFURA (5515-F-602) KGIRA (5515-F-602) KHPZA (5515-F-602) KKXKA (5515-F-602) JYTBD (5515-F-602) MNE6NM (70-3003L) MNE963 (70-3003R) MNEKXP (70-3007L) MNE58K (70-3007L) MNE6HL (70-3007L) MNE8MN (70-3007L) MNEV2Y (70-3007R) MNEVDV (70-3007R) MNEN3D (70-3009R) MNEX43 (70-3009R) MMMXTY (70-3013L) MNE2J2 (70-4104L) MNE0Y8 (70-4104L) MNDVDT (70-4104R) MND743 (70-4104R) MNEEE4 (71-3009L) MNE12D (71-3009L) MNEALW (71-3009L) MNEXLK (71-3009L) MNEXV0 (71-3009L) MNELHM (71-3009R) MNEYNE (71-3009R) MMR24J (71-3013L) MMAKX5 (71-4104L) MNDKJ7 (71-4503R) MMT7P8 (71-4503R) MMT8J3 (71-4503R) MNE5D4 (71-4504L) MNEHV1 (71-4504L) MNEL8W (71-4504R) MND272 (71-4504R) MNDD9D (71-4504R) MNAJ78 (71-4505L) MNAN2L (71-4505L) MMT4KY (71-4505L) MMTPH5 (71-4505L) MNDP2N (71-4505L) MMTEW1 (71-4505R) MNANVA (71-4505R) MNA062 (71-4505R) MNARAR (71-4506L) MNEL1Y (71-4506L) MNEW53 (71-4506L) MNAJ1W (71-4506L) MNALJA (71-4507L) MMT9R5X1 (71-4507L) MMTJRT (71-4507L) MND1V8 (71-4507L) MMT971 (71-4507L) MNEM55 (71-4507R) MND4WP (71-4507R) MNEAAD (71-4507R) MNA17E (71-4507R) MNAHJ9 (71-4509L) MND2HL (71-4509R) MND3TN (71-4509R) MND9AE (71-4509R) MMR28L (71-4509R) MNE0LE (80-4403L) MNEJ70 (80-4403L) MNEK3L (80-4403L) MNHTRK (80-4404R) MNERD1 (80-4405L) MNEY4A (80-4405R) MNEEND (80-4405R) MNEHN0 (80-4405R) MNEK42 (80-4405R) MNEMNR (80-4405R) MNEMXH (80-4405R) MNEH40 (80-4406L) MNA4HR (80-4406L) MNE769 (80-4407L) MNEXA8 (80-4407L) MNE37L (80-4407L) MNE9RD (80-4407L) MNEATP (80-4407L) MNEX06 (80-4407L) MNELAL (80-4407R) MNEPVE (80-4407R) MNEP9K (80-4407R) MNEX9T (80-4408L) MNE7H9 (80-4409L) MNEDWK (80-4409L) MNEDXN (80-4409L) MNE0R2 (80-4409R) MNETXP (80-4409R) MNEVTV (80-4409R) MNEWN4 (80-4411L) MNEN81 (80-4411L) MNDKD0 (80-6404R) MMTA8L (80-6405R) MNA175 (80-6405R) MMRV9D (80-6407L) MMP7T5 (80-6411L) MNE34H (81-4404R) MNE9WN (81-4404R) MNEKY7 (81-4404R) MNE3XK (81-4405L) MNE40R (81-4405L) MNE50T (81-4405L) MNE6A5 (81-4405L) MNE7NN (81-4405L) MNEDX6 (81-4405L) MNERR2 (81-4405L) MNE473 (81-4405L) MNE9DD (81-4405L) MNEJ0N (81-4405L) MNELK5 (81-4405L) MNEP17 (81-4405R) MNEPET (81-4405R) MNE5W5 (81-4405R) MNEA1T (81-4405R) MNEH09 (81-4405R) MNEPX6 (81-4405R) MNER3V (81-4405R) MNEWW7 (81-4405R) MNEXDP (81-4405R) MNEXLL (81-4405R) MNEY3R (81-4405R) MNE5PE (81-4405R) MNEK9M (81-4405R) MNEA42 (81-4406L) MNENAR (81-4406L) MNEW72 (81-4406L) MNE0J3 (81-4406L) MNE5D6 (81-4406L) MNEMD4 (81-4406L) MNEMPD (81-4406L) MNEHL1 (81-4406L) MNEM0H (81-4406L) MNEMJ8 (81-4406L) MNEPN6 (81-4406L) MNE1XK (81-4406R) MNE5D2 (81-4406R) MNED3A (81-4406R) MNEA75 (81-4406R) MNEYHH (81-4406R) MNEVLY (81-4406R) MNE3KJ (81-4407L) MNE8PT (81-4407L) MNE996 (81-4407L) MNEPYY (81-4407L) MNE127 (81-4407L) MNE26L (81-4407L) MNE63T (81-4407L) MNE71T (81-4407L) MNE6XK (81-4407L) MNE2NH (81-4407R) MNED83 (81-4407R) MNENY7 (81-4407R) MNEW56 (81-4407R) MNEXV1 (81-4407R) MNE217 (81-4407R) MNELEP (81-4407R) MNENM4 (81-4407R) MNEPEP (81-4407R) MNERAV (81-4407R) MNETYX (81-4407R) MNEWN0 (81-4407R) MNEX5E (81-4407R) MNHTW5 (81-4407R) MMPE33 (81-4407R) MNE0J9 (81-4407R) MNE3MH (81-4407R) MNE9J1 (81-4407R) MNEAR2 (81-4407R) MNEAXJ (81-4407R) MNEHHE (81-4407R) MNEVN7 (81-4407R) MNEW3Y (81-4407R) MNEXVT (81-4407R) MNEYR6 (81-4407R) MNE5YP (81-4407R) MNE525 (81-4407R) MNE6WT (81-4407R) MNE7V2 (81-4407R) MNEA62 (81-4407R) MNEY27 (81-4407R) MNE2VE (81-4408L) MNEAMY (81-4408L) MNEEM0 (81-4408L) MNEYRT (81-4408L) MNEYYK (81-4408L) MNEMLA (81-4408R) MNET9J (81-4408R) MNE089 (81-4408R) MNE7XV (81-4408R) MNE8N4 (81-4408R) MNE2A1 (81-4408R) MNE4DK (81-4408R) MNE9M9 (81-4408R) MNEA4T (81-4408R) MNEAJ8 (81-4408R) MNEV0Y (81-4409L) MNEY74 (81-4409L) MNEY57 (81-4409L) MNE4W5 (81-4409L) MNEEEN (81-4409L) MNE93H (81-4409L) MNE2DK (81-4409R) MNENLJ (81-4409R) MNER77 (81-4409R) MNEV0J (81-4409R) MNE159 (81-4409R) MNE1H2 (81-4409R) MNEM2D (81-4409R) MMTVXW (81-4411R) MMP0MP (81-4413L) MMTR58 (81-6404R) MMTDN7 (81-6407L)
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ALIMSA