It was reported that, after bhr total hip arthroplasty was performed, the patient experienced metallosis.This adverse event was treated with revision surgery on (b)(6)2022, in which the 42mm bhr resurfacing head was explanted.A liner and a new femoral head were implanted instead.Patient's current health status is unknown.
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H3, h6: it was reported that the patient was revised due to metallosis.The devices, used in treatment, were not returned for analysis.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the modular head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified for the part number and the reported/related failure mode.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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.No further actions are required at this time.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 required.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event additional medical/clinical records are received, the clinical task may be re-opened, and a thorough assessment will be rendered at that time.With the limited information provided, patient impact beyond the revision is unable to determined.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
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It was reported that, after bhr total hip arthroplasty was performed, the patient experienced metallosis.This adverse event was treated with revision surgery on
(b)(6) 2022, in which the 42mm bhr modular head was explanted.A liner and a new femoral head were implanted instead.Patient's current health status is unknown.
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