(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is getting pathology tested.The investigation is in process.Once the investigation has been completed, a follow-up mir 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.Concomitant products: part# 115370, lot 944340.Part# xl-115363; lot# 798550.Part# 113648; lot# 647510.Part# 118001; lot# 384530.Part# 115310; lot# 042090.Part# 180560; lot# 114970.Part# 180558; lot# 330140.Part# 180553; lot# 687720.Part# 180553; lot# 093880.Part# 115398; lot# 714870.Part# 115330; lot# 157840.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00424, 0001825034 - 2022 - 00425, 0001825034 - 2022 - 00427, 0001825034 - 2022 - 00428, 0001825034 - 2022 - 00429, 0001825034 - 2022 - 00430, 0001825034 - 2022 - 00431, 0001825034 - 2022 - 00432, 0001825034 - 2022 - 00433, 0001825034 - 2022 - 00434, 0001825034 - 2022 - 00435.
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It was reported that the patient underwent a reverse shoulder arthroplasty on an unknown date.Subsequently, in an unknown timeframe post-implantation, the patient was revised due to aseptic loosening with periprosthetic osteolysis, wear of the poly component, and metallosis.Attempts have been made and no further information has been provided.
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The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: a4; b4; b5; g3; g6; h1; h2 upon reassessment of the reported event, it was determined to be not reportable.Metallosis caused between the articulation of the tray and glenosphere is a secondary failure of the poly wear.Loosening is also a secondary failure of poly wear.The initial report was forwarded in error and should be voided.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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