SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number UNKN01102110 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Encephalopathy (1833); Metal Related Pathology (4530)
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Event Date 01/12/2017 |
Event Type
Injury
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Event Description
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It was reported that, six years after a revision surgery in which a bhr system had been replaced with a metal-on-metal system on both hips, the patient became severly disabled and was diagnosed with metallosis and arthroplastic cobalt encephalopathy.It is unknown if/how the patient has been treated.
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Manufacturer Narrative
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It was reported that the patient was diagnosed with metallosis.It is unknown if a revision surgery has been performed.The implanted devices, were all used in treatment.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.The complaint information was reviewed.However, no medical documents, lab reports or x-rays related to the reported event has been provided for inclusion in this investigation.Therefore, a thorough medical assessment is not able to be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without 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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It was reported that the patient underwent a right hip revision.The implanted devices, all of which were used in treatment & additional information has been requested for this complaint but has not become available.No part/lot numbers were provided hence a 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 documents were reviewed.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.Post removal levels of cobalt and chromium were not provided.Without 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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It was reported that the patient underwent a revision operation.As of today, the implanted devices, all of which were used in treatment & additional information has been requested for this complaint but has not become available.Since the device part details have not been received for investigation no thorough manufacturing record review can be performed.A risk management review was performed.No additional risks were identified as a result of the reported event.The medical documents were reviewed.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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