SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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Catalog Number 74120154 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 12/12/2018 |
Event Type
Injury
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Event Description
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*us legal mdl* it was reported that a revision surgery was performed on the patient right hip on (b)(6) 2018.The revision surgery was performed due to pain, limited mobility, metal debris, pseudotumor, and elevated metal ion levels.The cup was not explanted.The patient outcome is unknown.
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Manufacturer Narrative
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It was reported that a 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 and head 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 head.Similar complaints have been identified for the cup 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.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 clinical information provided, of report of the elevated metal ion levels, the metal debris, the metallosis and fibrinous tissue may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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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