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SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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| Catalog Number 74120152 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Unspecified Infection (1930); Optical Nerve Damage (1986); Toxicity (2333); Arthralgia (2355); Joint Dislocation (2374); Metal Related Pathology (4530)
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| Event Date 06/16/2010 |
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Event Type
Injury
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Manufacturer Narrative
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It was reported that the patient suffered from elevated chromium and cobalt levels.As of today, additional information have been requested for this complaint but have 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.The available medical documents were reviewed.Based on the provided information the source of the reported findings 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 expected post-operative healing/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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Event Description
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It was reported that the patient had a right hip surgery performed on (b)(6) 2010.Shortly after the patient was readmitted on the hospital due to infection and was treated with a i&d.The right hip remain unrevised.But the patient suffered from elevated chromium and cobalt levels.Although the right hip has not been revised, the right hip contribution to the elevated ion levels on blood cannot by discarded.
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Manufacturer Narrative
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It was reported that the patient suffered from elevated chromium and cobalt levels.This complaint relates to the right hip, which remains unrevised.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 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.Similar complaints have been identified and this will continue to be monitored.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.It was also confirmed that all devices were sterilised.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 reported wound dehiscence with purulent drainage may be consistent with infection; however, the root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.With the limited information provided, the root cause of the reported elevated metal ions cannot be confirmed and it cannot be concluded that the reported elevated ions were associated with a mal-performance of the implant.A february 2018 note indicated her joints were doing well.The patient impact beyond the elevated metal ions cannot be determined.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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Event Description
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It was reported that the patient had a right hip surgery performed on (b)(6) 2010.Shortly after the patient was readmitted on the hospital due to infection and was treated with a i&d.The right hip contribution to the elevated ion levels on blood cannot be discarded.
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Manufacturer Narrative
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Sections b5 and d10 were updated with the new information received.Internal complaint reference number: (b)(4).
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Manufacturer Narrative
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H3, h6: it was reported that shortly after right hip surgery the patient was readmitted to the hospital due to infection and was treated with an incision and drainage.Elevated ion levels were also reported.The right hip remains unrevised, but the contribution to the elevated ion levels cannot be discarded.As of today, the devices, all of which were used in treatment remain implanted and therefore cannot be returned for evaluation.Additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the acetabular cup and femoral head was performed, using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified to involve the batch for the cup and head, however these are for the same patient/lot.Other similar complaints have been identified for the part number and the reported failure mode for the cup and head in this timeframe, however these are for the same patient/lot.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical documents were reviewed.The reported wound dehiscence with purulent drainage may be consistent with infection; however, the root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.With the limited information provided, the root cause of the reported elevated metal ions cannot be confirmed and it cannot be concluded that the reported elevated ions were associated with a mal-performance of the implant.A (b)(6) 2018 note indicated her joints were doing well.The patient impact beyond the elevated metal ions cannot be determined.Without the return of the devices or additional information we cannot advance our investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated as there were no manufacturing, design or labelling deficiencies identified which would have contributed to the complaint.
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