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Us legal: it was reported that, after a left bhr-tha was performed on (b)(6) 2011 due to hypertrophic osteoarthritis, the patient experienced a left infection and inflammatory reaction due to elevated serum cobalt and chromium levels.This adverse event was treated with a left revision surgery on (b)(6) 2021, in which a spacer replacement/synovectomy, bone excision and a trochanteric osteotomy repair were performed.Patient's current health status is unknown.
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It was reported that left revision surgery was performed due to infection and inflammatory reaction due to elevated serum cobalt and chromium levels.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, this will continue to be monitored.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.The acetabular cup 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 mode 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 product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.Although it was reported the serum cobalt and chromium levels were elevated, neither the levels nor laboratory reports were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported events and intraoperative findings cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.Based on the available information, including the operative notes, 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 device 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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