SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number UNKNOWN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Injury (2348); Metal Related Pathology (4530)
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Event Date 10/08/2020 |
Event Type
Injury
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Event Description
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It was reported that, after a bhr construct from smith & nephew had been implanted on the left hip, the patient had high metal ion levels.A revision surgery was scheduled to remove the implants, but it was cancelled for the patient did not want further smith & nephew products implanted.It is still unknown if the patient problem has been addressed yet.
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Manufacturer Narrative
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It was reported that a patient cancelled their scheduled bhr revision for personal reasons.All of the implanted devices were used in treatment.As of today, additional information has been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.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.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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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Search Alerts/Recalls
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