(b)(4).Concomitant medical products: catalog #: 00830004300, tibial base component size 3, lot # 63342717, catalog #: 00830002300, talar component size 3 right, lot # 62946236, catalog #: 00493500903, one-third tubular plate with collar, lot # 63518815.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019 -03610, 0001822565-2019-03611, 0001822565-2019-03612, 0001822565-2019-03615.Remains implanted.
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It was reported that the patient underwent primary ankle approximately two years ago.Subsequently at the two year visit the patient was experiencing moderate pain, restricted rom, drainage, and was noted to have impingement.A month ago the patient underwent arthroscopic & debridement procedure, the implant remains implanted.
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This follow-up report is being submitted to relay additional information.Correction: a1.Reported event was confirmed by review of medical records/radiographs.Review of the available records identified the following: no complications reported from the initial procedure.Patient underwent arthroscopic & debridement procedure.Validated post debridement, no impingement.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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