It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip on (b)(6) 2012, the patient experienced pain and was diagnosed with metallosis in her left hip.A revision surgery was conducted on (b)(6) 2021 to treat this adverse event.During this procedure, the bhr resurfacing head was explanted and a competitor¿s dual mobility liner with a replaced femoral component were chosen as new components.The patient¿s outcome is not known.
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Results of investigation: it was reported that a left hip revision surgery was performed due to pain and metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the acetabular cup and for the femoral head.However, as the 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.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.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 are required.The available medical documents were reviewed.It should be noted the revision operative report did not note any findings consistent with the reported metallosis.With the information provided the clinical root cause of the reported metallosis cannot be confirmed and it cannot be concluded the reported clinical reaction was associated with a mal performance of the implant or implant failure.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, loosening of components may increase production of wear particles and accelerate damage to the bone.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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