(b)(4).Concomitant medical products: catalog#: 010000925, g7 hi-wall e1 liner 32mm c, lot#: 6891193.Catalog#: 010000925, g7 hi-wall e1 liner 32mm c, lot#: 6891193.Catalog#: 010000847, g7 neutral e1 liner 32mm c, lot#: 6383693.Catalog#: 010000661, g7 pps ltd acet shell 48c, lot#: 6911325.Catalog#: 51-130100, tprlc 133 fp 12/14 bm so 10.0, lot#: 6762943.Catalog#: 650-0834, delta cer fem hd 032/0mm 12/14, lot#: 3068587.Catalog#: 650-0833, delta cer fm hd 032/-4.0 12/14, lot#: 3061363.Catalog#: 010000997, g7 screw 6.5mm x 20mm, lot#: 6912020.Catalog#: 010000998, g7 screw 6.5mm x 25mm, lot#: 6801958.Catalog#: 010000998, g7 screw 6.5mm x 25mm, lot#: 7012456.Catalog#: 010000999, g7 screw 6.5mm x 30mm, lot#: 6730917.Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2021-02272, 0001825034-2021-02273, 0001825034-2021-02274, 0001825034-2021-02276.
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It was reported that the insert did not fit inside the cup, although multiple attempts.As a result, the cup sunk into the acetabulum.The cup has been removed and reinserted after acetabulum reinforcement by the means of screws.A new high-wall insert has been repositioned without success.A third attempt was done by inserting a standard insert, without success.The surgeon decided to definitely remove the cup and to bore the acetabulum to obtain a more equatorial grip.A new high-wall insert has been positioned but it did not fit inside the new cup.In the end, a standard insert has been successfully inserted inside the cup.No adverse events were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations could not be performed as no pictures were provided or product returned.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined for items 010000661 (48c shell) and 010000925 (32c liner), 010000847 (32c liner), not seating.The root cause of item 010000661 (48c shell) and 010000936 (36f liner) not seating is directly related to these components not being compatible per the g7 acetabular system surgical technique.Additionally, it is stated in the technique that the color on the liner label should match the color anodized on the rim of the acetabular shell.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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This follow-up report is being submitted to relay additional information.A g7 hi-wall e1 liner 36mm f, part # 010000936 from lot 6913032, was returned and evaluated against the complaint.Visual inspection found a circular indentation on the outer radius of the liner.The radius of the indentation is smaller than that of the returned screws.Pitting and scratching were also observed on the outer radius of the liner.Upon further review it was discovered that the size f liner was used with a size f cup which is compatible thus the compatibility and root cause determinations have been updated to not determined.Root cause was unable to be determined.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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