SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74121146 |
Device Problem
Compatibility Problem (2960)
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Patient Problems
Arthralgia (2355); Limited Mobility Of The Implanted Joint (2671)
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Event Date 04/24/2018 |
Event Type
Injury
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Event Description
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It was reported that, after a left-sided bhr arthroplasty had been performed, the patient started suffering pain, limited mobility, and elevated metal ion levels.The adverse event was treated with a revision surgery: both the acetabular cup and the femoral head were explanted.The patient outcome is unknown.
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Manufacturer Narrative
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H3, h6: it was reported that left hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup & bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided of the pain and fluid may be consistent with a reaction to metal debris.However, the report does not mention the common signs usually present with reactions to metal debris.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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