Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi # is unavailable.(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that patient scheduled for knee revision due to instability and pain.Severe laxity noted with well aligned and well fixed implants.No records were able to be located relating to plant time or implants used, however, it is a cr rp sigma knee.Significant deformation/wear was noted on the posterior aspect of the medial side of the insert.No patient harm was noted.By going to a thick insert, the knee was found to be well balanced and quite stable.Doi: unknown.Dor: (b)(6) 2022.Affected side: right knee.
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