(b)(4).Concomitant medical products: item# 110017106 g7 finned 4 hole shell 58g lot# 6363413, item# unknown unknown head lot# unknown, item# unknown unknown stem lot# unknown, item# 010000820 g7 hi-wall arcomxl lnr 36mm g m g lot# 6346580.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, 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 - 00308, 0001825034 - 2019 - 00305.
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It was reported that during initial surgery for implantation, liner would not seat in shell.Surgeon attempted a different liner and it would not seat as well.Surgeon explanted cup and then seated liner with first attempt.Procedure was delayed 45 minutes.Attempts were made to obtain additional information; however, none is available.
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