(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item number: 010000666, item name: g7 acetabular shell, lot #: 6295711.Item number: 010000985, item name: g7 freedom constrained liner, lot #: 6272326.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08216, 0001825034-2018-08218.
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(b)(4).This follow-up report is being submitted to relay additional information.Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Upon receipt, the liner was assembled with the shell.The rim of the liner is gouged.The inner radius of the liner exhibits a few scratches.Scuffing was observed on the outer radius of the liner after it was removed from the shell as described above.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08216 - 1 , 0001825034 - 2018 ¿ 08218 - 1.
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