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Bilateral patient.It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s right hip on (b)(6) 2009, the patient experienced pain, elevated cobalt ion levels in blood and pseudotumor formation.A mars mr scan showed a local adverse tissue reaction in the right hip.A revision arthroplasty was conducted on (b)(6) 2022 to treat this adverse event.During this procedure, the bhr acetabular cup and resurfacing head were explanted and replaced with a competitor¿s thr system.The patient¿s outcome is unknown.
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It was reported that a right hip 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 acetabular cup and the femoral head 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 complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode for the acetabular cup.No other complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported/related failure mode for the femoral head.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 elevated cobalt was reported, no units of measure nor lab reports were provided.The reported pain, elevated cobalt and pseudotumor may be consistent with findings associated with metal debris.However, the source of the pain, elevated cobalt, and pseudotumor cannot be confirmed and it cannot be concluded that the reported events/clinical reactions were 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 information provided we cannot confirm or further investigate the reported complaint, 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.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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