(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-02712.Concomitant medical products: tibial component precoat right medial/left lateral size 2, item# 00584200202, lot# 11017015.Articular surface size 2 8 mm height femoral size a,b,c,d,e,f,g, item# 00584202208, lot# 62972567.Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up is being submitted to relay additional information.Visual examination of the provided pictures identified implant with bone cement/tissue/bone attached to back of the implant.Some wear was seen in the articular surface.No further evaluation can be made from the provided picture.Medical records were not provided.However, review of small note provided by the customer noted no issue during the initial surgery.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert 87-6203-012-01: loosening is known adverse effect of the procedure.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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