(b)(4).Concomitant medical products: series-a standard patella 34mm x 8.5mm, catalog #: 184766, lot #: 409610.Biomet splined knee stem v2 with screw 18mm x 40mm, catalog #: 148293 ,lot #: 269100.Vanguard ssk 360 femoral component left 72.6mm, catalog #: 185287, lot #: 6053604.Vanguard 360 revision posterior augment with bolt, catalog #: 185347, lot #: 862360, 5mm x 72.5mm.Vanguard 360 revision distal femoral augment with bolt 5mm x 72.5mm, catalog #: 185307, lot #: 186000.Biomet 360 tibial tray 79mm, catalog #: 185205, lot #: 883210.Biomet 360 tibial cruciate wing, catalog #: 185651, lot #: 700880.Biomet 360 offset adapter 2.5mm, catalog #: 185210, lot #: 371710.Biomet 360 tibial augment 10mm x 79mm, catalog #: 185235, lot #: 830830.Biomet splined knee stem v2 with screw 17mm x 40mm, catalog #: 148292, lot #: 945540.Vanguard posterior stabilized tibial bearing 12mm x 79/83mm, catalog #: 185102, lot #: 449000.Vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm, catalog #: 185102, lot #: 237190.Biomet tibial locking bar, catalog #: 141205, lot #: 966260.Vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm, catalog #: 185102, lot #: 055590.Biomet tibial locking bar, catalog #: 141205, lot #: 478950.Vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm, catalog #: 185102, lot #: 018270.Biomet tibial locking bar, catalog #: 141205, lot #: 889430.Vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm, catalog #: 185102, lot #: 018270.Biomet tibial locking bar, catalog #: 141205, lot #: 588070.Tibial knee cement mold 80mm, catalog #: 433180, lot #: 014870.Femoral knee cement mold 70mm, catalog #: 432170, lot #: 202630.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device remains unknown at this time.Review of the device history records identified no related deviations or anomalies during manufacturing.Review of the sterile certificates indicates that the products were sterile when they were released from zimmer biomet control.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 patient; please see all reports associated with this event: 0001825034-2018-10745, 0001825034-2018-10746, 0001825034-2018-10747, 0001825034-2018-10749, 0001825034-2018-10750, 0001825034-2018-10751, 0001825034-2018-10752, 0001825034-2018-10753, 0001825034-2018-10754, 0001825034-2018-10755.
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