SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number UNKNOWN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Event Description
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It was reported that, after a tha in which a bhr construct had been implanted on the right hip, the implants failed in an unknown way.The patient underwent a unknown revision surgery 10 years ago to treat the adverse event; the patient received a metal-on-metal system instead.
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Manufacturer Narrative
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It was reported that the patient underwent an unknown revision surgery 10 years ago on the right hip, due to the failure of the implants.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.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
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Manufacturer Narrative
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It was reported that the patient underwent an unknown revision surgery 10 years ago on the right hip, due to the failure of the implants.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.No part/lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.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 medical records were reviewed.In conclusion, based on the clinical information provided, of the elevated metal ion levels and the effusions may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The symptoms and details around his reported encephalopathy were not provided.Post removal levels of cobalt and chromium were not provided.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
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Search Alerts/Recalls
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