Alerta De Seguridad para LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component

Safety alert

2013-07-19

2013-07-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130719a.html

Medical device safety alert: depuy lps (limb preservation system) lower extremity dovetail intercalary component it has come to our attention that the medical device manufacturer, depuy orthopaedics, inc. has initiated a field safety corrective action concerning its lps (limb preservation system) lower extremity dovetail intercalary component. the affected part number is 1987-19-055. according to the manufacturer, the affected product has the potential for fracture of the female component when exposed to certain physiological loads. bench testing simulating loads under normal walking conditions demonstrated that patients over approximately 200 lbs. (90 kg) are at higher risk and that increasing weight may pose increasing risk. however, common activities such as stair ascent and descent and rising from chairs may exert forces higher than those under normal walking conditions. other factors such as the patient’s musculature, activity level, and overall health should also be considered. the possible clinical implications related to this issue, which could only occur if the product should fracture, include: poor mechanics and loss of function pain dislocation: the separation of the male component from the female component adverse tissue reaction if the broken piece of the female component were to completely break free and cause irritation to the surrounding tissue. damage to bone in areas that are important for revision surgery. surgeon may be unable to conduct revision surgery due to lack of sufficient bone stock, potentially resulting in amputation if no other therapeutic options remain available. the clinical implications above may lead to revision surgery. depuy provides the following advice to the affected customers: customers are advised to stop further distribution or use of the affected products immediately for use in primary surgery. depuy is not recommending prophylactic revision in the absence of symptoms. however, surgeons are encouraged to communicate with patients who received these implants as deemed appropriate (considering weight and activity level). depuy recommends that surgeons review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors. if a patient presents with a fractured lps lower extremity dovetail intercalary component with well‐fixed proximal and distal stems and the surgeon determines that the lps lower extremity dovetail intercalary component is the best treatment option, the company will make the lps lower extremity dovetail intercalary component available. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2013.