SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Model Number 74121146 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Metal Related Pathology (4530)
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Event Date 11/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Complaint reference: (b)(4).
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Event Description
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Plaintiff underwent medically-indicated revision of the bhr right hip implants on (b)(6) 2018.The patient revision surgery was performed due to severe pain, failed right hip resurfacing, stiffness, loss of mobility, metallosis, pseudotumor, necrosis, and adverse tissue reaction.The cup and head were explanted.The patient outcome is unknown.
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Manufacturer Narrative
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It was reported that right hip revision surgery was performed.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 and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.A similar complaint has been identified for the head.This will continue to be monitored.A similar complaint has been identified for the cup.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the 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.The available medical documents were reviewed.The clinical information provided, for the first revision, of the reported elevated metal ion levels, metallosis, necrosis, and adverse tissue reaction, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.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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