(b)(4).Medical product: partial tibial cemented catalog # 42538000701, lot # 65036968.Biomet bc r 1x40 us catalog # 110035368, lot # zz44bj2604.Partial articular surface left medial size g 9 mm thickness catalog # 42518200709 lot # 64660677.Component code - mechanical, femur.Multiple mdr reports were filled for this event: 0001825034-2023-00871.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Medical records review indicates the following mri impression states artifact limiting study with small knee effusion.No loosening can be confirmed based on this mri report.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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