It was reported that, after a left hip bhr-tha construct had been implanted on (b)(6) 2008, the patient experienced elevated cobalt and chromium ion levels in blood.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, the modular femoral head was explanted and replaced with an oxinium head and a dual-mobility polyethylene liner.The acetabular and femoral component were left in situ.Intraoperatively, a dark colored debris at the taper junction was noticed upon removing the modular head and sleeve, although the trunnion was intact.The patient tolerated well the procedure and was transported to the recovery room in stable condition.
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G5: pma/510(k) # section h3, h6: it was reported that, after a left hip revision surgery was performed due to elevated cobalt and chromium ion levels in blood.Intraoperatively, a dark colored debris at the taper junction was noticed.During this procedure, the modular femoral head was explanted and the acetabular and femoral component were left in situ.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 hemi head and the modular sleeve.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.The review of the products 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.The reported elevated cobalt and chromium and intraoperative findings of hypertrophic synovium, and metal-on-metal dark colored debris at the taper junction of the trunnion may be consistent with the reported metallosis.However, the clinical root cause of the reported clinical reactions cannot be definitively concluded.It cannot be concluded the reported clinical reactions were associated with a malperformance of the implant or implant failure.Based on the information provided, 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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