(b)(4).Medical devices: item# 010000857 g7 neutral e1 liner 36mm e lot# 6316589, item# 00-6250-065-20 trilogy bone scr 6.5x20 lot# trilogy bone scr 6.5x20, item# 00-6250-065-20 trilogy bone scr 6.5x20 lot# 63530640, item# unknown, unknown head lot# unknown, item# unknown, unknown stem lot# unknown.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 - 2018 - 10840.
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It was reported, surgeon had difficulty inserting shell.Shell was placed.Surgeon then had difficulty getting liner to hold in the shell.After multiple attempts, the liner engaged but the surgeon noted that the shell had become loose in the acetabular bone.The shell/liner was removed and a new shell was cemented into patient.Attempts were made to obtain additional information; however, none was available.
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