Zimmer biomet complaint (b)(4).Medical product- vanguard xp interlock femoral component catalog# 195203 lot# 822670; vanguard xp tibial tray catalog# 195246 lot# 833150; vanguard xp tibial bearing rm catalog# 195397 lot# 883620; vanguard tibial bearing rl catalog# 195327 lot# 908020; biomet series a thin patella catalog# 184784 lot# 976820 the instrument was not returned for evaluation due to unknown location.Review of the device history record (dhr) was not performed due to unknown lot number provided.Review of the complaint history identified four additional complaints associated with the part (catalog) number.Without an opportunity to examine the instrument, the root cause could not be determined and the event could not be confirmed.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, "incorrect assemble of/to mating instruments¿.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.This report is being submitted late as it has been identified in remediation.
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