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
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Local Reaction (2035); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
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Event Type
Injury
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Event Description
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It was reported that right hip revision surgery was performed due to pain, adverse local tissue reaction, fluid build up and necessity of a walker for mobility purposes.
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Manufacturer Narrative
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It was reported that right hip revision surgery was performed.During the revision, the acetabular cup, modular sleeve and the hemi head were removed.As of today, 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 acetabular cup, hemi head and modular sleeve 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 acetabular cup.Similar complaints have been identified for the hemi head and the modular sleeve.However, as the device is no longer sold, no action is to be taken.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.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 available medical documents were reviewed.The reported pain, adverse local tissue reaction, elevated cobalt level and intra-operative findings of purulent looking fluid may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the limited information provided.Without supporting post-primary radiographic images, lab/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, and there is no report of the patient¿s current condition, or whether the reported clinical symptoms persist.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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It was reported that right 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 cup / head / sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the cup.Similar complaints have been identified for the head & sleeve.However, as these devices are no longer sold, no action is to be taken.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 documents were reviewed.The reported pain, altr, elevated cobalt level and intraoperative findings of purulent looking fluid may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the limited information provided.Without supporting post-primary 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, and there is no report of the patient¿s current condition, or whether the reported clinical symptoms persist.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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