(b)(4).Concomitant medical products: item#: unknown, unknown head, lot#: unknown.Item#: unknown, unknown stem, lot#: unknown.010000938, g7 hi-wall e1 liner 36mm h, 6592108.110010269, g7 osseoti multihole 62mm, h 6500439.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: 0001825034-2019-5047, liner 2.0001825034-2019-05082, cup.
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It was reported during an acetabular revision, a size 62 multihole osseoti cup was placed.Liner would not seat upon impaction.Liner was removed, cup was cleaned, screws were checked to ensure they were not proud.Tried this 4 more times and liner would not seat.Left hospital to go get a new liner.New liner would not seat.Surgeon commented it appeared to get hung up in same spot both times.There was no medial wall.Surgeon hit the liner hard but was cautious to hit too hard because of the suspect fixation and lack of medial support.Went to a dual mobility liner and it seated.Sixty minute delay, had to drive to different hospital to get a replacement liner.Attempts were made to obtain additional information; however, none was available.
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