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It was reported that, the patient underwent a r3 total hip arthroplasty (right hip) on (b)(6) 2010 due to hip dysplasia.Severe deformities of acetabulum and proximal femur with complete loss of normal articular cartilage and a 30 mm limb length discrepancy on the right side.The patient, due to his continued pain and disability, decided to proceed with a revision surgery of the right hip.It was noticed osteolysis on x-ray and on radiological image a failure of the tha with mom articulation with elevated metal ions.The revision surgery was performed on (b)(6) 2022 where the r3 chrome-cobalt liner was explanted.Intraoperatively, necrotic tissue was seen.After the procedure the patient was taken to the recovery room in stable condition.
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H3, h6: it was reported that a right hip revision surgery was performed due to osteolysis and elevated metal ions, necrotic tissue was seen intraoperatively.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 r3 44mm id us cocr lnr 56mm was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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 to involve this batch.Other complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported failure mode.However, as the device is 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.Although the reported elevated metal ions, necrotic tissue and minimal staining of the trunnion may be consistent with metal debris and trunnionosis, the clinical root cause of the reported clinical reactions/event cannot be confirmed.It should be noted however, the patients¿ multiple previous operative interventions, and significant deformities cannot be ruled out as contributing factors to the reported events.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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