Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2020-00596, 0001032347-2020-00598, 0001032347-2020-00599.Medical products: tmj system right standard mandibular component 50mm / 9 hole, part# 24-6550, lot# 851360.Tmj system right fossa component, medium, part# 24-6560-int, lot# 934560.Tmj system left standard mandibular component 55mm / 12 hole, part# 24-6556, lot# 790490.Tmj system left fossa component, small, part# 24-6563-int, lot# 934590.Unknown screws, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d4; g3; g4; g6; h1; h2; h3; h4; h6.D4: sterile date - unknown.H4: manufacturing date - unknown.Product id is being updated to unknown part and lot numbers, as the originally reported product id was incorrect.The investigation is still in process.If any further information 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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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2 upon receiving additional information of the reported event, it was determined to be not reportable, as only the mandibular component was revised.The initial report should be voided.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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