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It was reported that, a plaintiff underwent a left primary tha-bhr surgery on (b)(6) 2009, and then started developing symptoms consistent with alval ten years later.Therefore, a revision surgery was carried out on (b)(6) 2021, during which an inguinal synovial herniation was found and treated, and the bhr acetabular and femoral head components were exchanged for competitor devices.No further complications were reported.
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H3, h6: it was reported that, a plaintiff underwent a left primary total hip arthroplasty-bhr surgery, and then started developing symptoms consistent with alval ten years later.Therefore, a revision surgery was carried out, during which an inguinal synovial herniation was found and treated, and the bhr acetabular and femoral head components were exchanged for competitor devices.No further complications were reported.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 alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Other similar complaints were identified for the cup and none for the head and sleeve.This will continue to be monitored for the cup, and will continue to be monitored via routine trending for the head and sleeve, however it should be noted that these devices are no longer sold.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 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, no prior applicable escalation actions were identified for the cup and sleeve, and prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible for the modular head.No further escalation actions are required.The available medical documents were reviewed.A clinical root cause could not be determined: the reported alval, and intraoperative findings of fluid effusion, slightly cloudy-yellowish fluid, and greyish discoloration on the entire morse cone, may be consistent with metal debris and/ or the herniation.However, the clinical root cause of the clinical reactions cannot be definitively confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the reported revision could not be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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.¿se pega el roi¿.
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