It was reported that after a bhr performed on (b)(6) 2020, the patient experienced unspecified symptoms that made a revision surgery necessary, which was performed on (b)(6) 2020.The limb side and the identity of the explanted devices and the ones implanted in exchange is unknown at this time.No further information is available.
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H3, h6: it was reported that the patient experienced unspecified symptoms that made a revision surgery necessary, which was performed on (b)(6) 2021.No further information is available and the devices, used in treatment, were not available for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / instructions for use review could not be performed.If more information is received, this investigation will be reopened.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.A risk management review was performed for the acetabular cup.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.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.If additional clinically relevant materials are later received, then the case may be re-evaluated.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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