(b)(4).The device was not returned for evaluation due to unknown location.Review of the device history record (dhr) found no deviations or anomalies.Review of complaint history for same issue identified eleven complaints for part (catalog) number and no complaints identified for lot number.Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Associated risk table lists "miscellaneous user needs (general post-operative pain )¿.Following review, no new risks were identified.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: 0001825034-2017-11064/11065/11067/11068/11069/11070/11071/11074.This report is being submitted late as it has been identified in remediation.
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It was reported that following an unspecified shoulder procedure on (b)(6) 2014, a female patient indicated at the one year follow up visit that she experienced problems with usual work and moderate pain.No further information was provided and patient's outcome is unknown.Attempts to obtain further information were performed, yet no additional information was provided.
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