(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544, 0001825034-2022-02545 and 0001825034-2022-02546.Concomitant medical products: item#: ti-115310, comp vrsdl glnspr 36mm ti, lot#: 621130, item#: 010000589, comp rvrs 25mm bsplt ha+adptr, lot#: 634750, item#: 115340, comp rvs hmrl ti tray 44mm, lot#: 738490, item#: 113633, comp primary stem 13mm mini, lot#: 336010, item#: 180553, comp lk scr 3.5hex 4.75x30 st, lot#: 628290, item#: 180553, comp lk scr 3.5hex 4.75x30 st, lot#: 628290, item#: 115394, comp rvs cntrl 6.5x20mm st/rst, lot#: 011400.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544-1.0001825034-2022-02545-1.0001825034-2022-02546-1.0001825034-2022-02567-1.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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.
|
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544-2; 0001825034-2022-02545-2; 0001825034-2022-02567-2.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.
|
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02544-3, 0001825034-2022-02545-3, 0001825034-2022-02567-3.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Previous root cause remains unchanged, a definitive root cause cannot 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.
|