(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00231 and 0001825034-2020-00232.Concomitant medical products: mod arthro nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 236860.Mod arthro nl 1 cm diasl cnctr, catalog#: cp260605, lot#: 161950.Oss porous im stem 21.5 x 150, catalog#: 150400, lot#: 360910.Oss porous im stem 18.5 x 225, catalog#: 150405, lot#: 898500.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that during a revision of a left knee oss system due to a broken junction/connector component, the surgeon stated that the morris taper could not be broken from the femoral stem despite multiple attempts and different instruments.The surgery had to be modified to cut the segments apart, extending surgical time by an hour.
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