It was reported that, after undergoing left hip bhr resurfacing procedure due osteoarthritis, the patient experienced increasing pain in the left hip with systemic manifestations of metallosis.This adverse event was treated with revision surgery on (b)(6) 2020.During this procedure, a little bit of blackened debris was noted.The resurfacing femoral head was explanted.Patient's current health status is unknown.
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H3, h6: it was reported that left hip bhr revision surgery was performed.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 femoral head.Similar complaints have been identified for the acetabular cup.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 required.The available medical documents were reviewed.Although the pain, and intraoperative findings of some inflammatory tissue and a little bit of blackened debris may be consistent with the reported metallosis, the source of the metallosis cannot be confirmed, and it cannot be concluded that the metallosis was associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.Based on the available information we can confirm the reported complaint, however without further information 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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