Country of origin (b)(6).Zimmer biomet complaint (b)(4).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was confirmed.A review of the mhr indicates there was no non-conformance during the production of the released product.Further inspection indicates areas of deformation on the product, this damage likely occurred during the procedure.It should be noted that plastic deformation can occur easily when polyethylene liners are impacted in an attempt to lock them into place.Dhr was reviewed and no discrepancies were found.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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It was reported that patient underwent a total hip arthroplasty, during the procedure, the surgeon had trouble seating the liner in the cup, several attempts were made.Another liner was opened and used to complete the procedure.No patient adverse event was reported in association with this issue.
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