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H3, h6: it was reported that a right bhr revision surgery was performed due to pseudotumor.Necrosis and metallosis in the soft tissues were found intraoperatively.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the acetabular cup.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints were identified.However, as the device is no longer sold, no action is to be taken.As no device batch number was provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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 product 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.The reported necrosis and pseudotumor are consistent with the metallosis noted intraoperatively; however, with the information provided the clinical root cause of the reported metallosis cannot be confirmed.It should be noted however, the retroversion of the native acetabulum and uncoverage superolaterally as well as posteriorly, superiorly due to the retroversion cannot be ruled out as contributing factors to the necrosis, pseudotumor, and metallosis.It cannot be concluded the reported events/ clinical reactions were associated with a malperformance of the implant.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 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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