(b)(4).(udi): (b)(4).Associated products : item#: 178364; cps xs sht spdl w pins 800lbf; lot# 662280, item#: 178562; cps short anchor plug 20mm; lot# 608710, item#: 178526; cps transverse pin 6pk 28mm; lot# 965300.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03992, 0001825034-2020-00479, 0001825034-2020-00481.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Reported event was confirmed by review of medical records, which identified patient has audible clicking and radiographs show anchor plug has collapsed with loosening of hardware.During the revision procedure the implant was noted to be frankly loose at its bone interface as it had collapsed down the bone completely.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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