(b)(4).113629 232620, comp primary stem 9mm mini; 115370 732290, comp rvs tray co 44mm; xl-115363 169790, arcom xl 44-36 std hmrl brng; 115310 861840, comp rvrs shldr glnsp std 36mm; 115396 915970, comp rvs cntrl 6.5x30mm st/rst; 180552 542870, comp lk scr 3.5hex 4.75x25 st; 180553 425740, comp lk scr 3.5hex 4.75x30 st; 180552 261910, comp lk scr 3.5hex 4.75x25 st; 180555 030210, comp lk scr 3.5hex 4.75x40 st.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 event, please see associated reports: 0001825034-2019-03425, 0001825034-2019-03426, 0001825034-2019-03427, 0001825034-2019-03429, 0001825034-2019-03431, 0001825034-2019-03432, 0001825034-2019-03433, 0001825034-2019-03434, 0001825034-2019-03435.Product remains implanted.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Review of medical records identified that the patient had hard lump small amount of pus drainage 2 days prior to visit.Had no drainage post antibiotic intake.Extremity warm well perfused, with normal pulses.Small area of redness < 0.5cm at the superior aspect of the incision without active drainage, streaking, or visible suture.No underlying deeper abscess is evident.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not 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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