(b)(4).Concomitant medical products: item# 010000662, g7 pps ltd acet shell 50d, lot# 6289152.Item# 010000856, g7 neutral e1 liner 36mm d, lot# 6289818.Item# 51-130100, tprlc 133 fp 12/14 bm so 10.0, lot# 6246373.Item# 010000996, g7 screw 6.5mm x 15mm, lot# 3716836.Item#650-0836, biolox delta modular ceramic head 32mm-4mm neck type12/14taper, lot# 2018012043.Report source: foreign source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2019-01367, 0001825034-2019-01364, 0001825034-2019-01363, 0001825034-2019-01362, 0001825034-2019-01478.
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(b)(4).Surgeon notes there was a wound dehiscence occurred at some point.There was washouts (i&ds) performed & antibiotic treatments given till revision was done.Infection (klebsiella) was cultured from the acetabulum only.Infection occurred within 1 yr post procedure.Klebisella is a known bacteria to be related to joint infections, as well as pneumonia, urinary tract infections and blood infections.It is unknown if the patient had an existing infection while the initial procedure was performed, which could be a contributing factor as well as patient was noted to be morbid obese, which increases the risk for infections post op.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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