1 of 3 reports.Same patient, same procedure, different parts.Other mfg report numbers: 1651501-2021-00019 and 1651501-2021-00020.Report from a clinical study: revision surgery performed of polyethylene insert due to pain without evident reason.Subject sustained chronic ankle pain after the surgery.The event was reported to be continuous and of moderate severity.The investigator reported no relation to the study device however a possible relationship to the procedure (primary ankle arthroplasty).
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Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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