SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74121150 |
Device Problems
Naturally Worn (2988); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)
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Event Date 08/21/2019 |
Event Type
Injury
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Event Description
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It was reported that a left hip revision surgery was performed due to unexplained pain, difficulty walking, elevated test results, and metal-on-metal wear.
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Manufacturer Narrative
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It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head and cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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.No further actions are required at this time.The medical records were reviewed.Based on the information provided, the reported pain and elevated cocr levels may be consistent with findings associated with metal debris.Without supporting radiographic images, pathology results and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain cannot be determined.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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Manufacturer Narrative
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New information: g4, d4.
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Search Alerts/Recalls
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