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 Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/03/2021 |
Event Type
Injury
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Event Description
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It was reported that, after an unspecified metal on metal hip construct had been implanted on the patient¿s hip on (b)(6) 2011, the patient sustained an unspecified injury and required a revision surgery on (b)(6) 2021.The identity of the explanted devices and the prosthesis implanted in exchange is unknown.The patient¿s outcome is unknown.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6.It was reported that the patient sustained an unspecified injury and required a revision surgery on (b)(6) 2021.The identity of the explanted devices and the prosthesis implanted in exchange is unknown.The patient¿s outcome is unknown and the devices, used in treatment, were not returned for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.A risk management review was performed for the acetabular cup and femoral head.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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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H3, h6: it was reported that the patient sustained an unspecified injury and required a revision surgery on (b)(6) 2021.The identity of the explanted devices and the prosthesis implanted in exchange is unknown.The patient¿s outcome is unknown and the devices, used in treatment, were not returned for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / instructions for use review could not be performed.If more information is received, this investigation will be reopened.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.A risk management review was performed for the acetabular cup and femoral head.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.A clinical root cause could not be determined: the reported pain, moderate joint effusion, and adverse local tissue reaction may be consistent with metal debris however, a clinical root cause of the pain, moderate joint effusion, and adverse local tissue reaction could not be confirmed.The patient impact beyond the reported revision could not be determined.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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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