(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: part: 010000668, g7 pps ltd acet shell 62h, lot: 3807464.Part: 010000743, g7 neutral arcomxl lnr 36mm h, lot: 6238012.Part: 010000998, g7 acetabular screw, 6.5 x 25 mm, lot: 6465835.Part: 010000998, g7 acetabular screw, 6.5 x 25 mm, lot: 6242427.Part: 650-1057, 36 head, ceramic, lot: 2958835.Part: 193013, echo bimetric microplasty hip stem, lot: 647390.Part: 650-1066, taper adapter, type i, lot: 2959105.Multiple mdr reports were filed for this event, please see associated reports: cup: 0001825034-2019-04738.Liner: 0001825034-2019-04736.
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was unconfirmed.Upon visual inspection there is no damage to the shell.Both of the returned liners showed scuffing on the outside diameter and damage to the locking feature that could have caused event.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant by email.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.
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