(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Age: year of birth (b)(6).Concomitant medical products: item number: 192112, item name: echo femoral stem item lot: 911630, item number: 010000662, item name: g7 acetabular shell, item lot: 6161079, item number: 010000848, item name: g7 neutral e1 liner, item lot: 3606652.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03856, 0001825034 - 2019 - 03858, 0001825034 - 2019 - 03859.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
This follow-up report is being submitted to relay additional information.Reported event was confirmed with operative notes provided.Post surgery operative notes were reviewed and identified patient experienced wound discharge.Delayed wound healing.2 surgical interventions performed.Additional operative notes identified aspirated yellowish fluid mixed w/blood 1 ml.Blood results crp 6, normal wbc, slightly elevated platelets.Additional operative notes identified aspirated 5ml of normal colored synovial fluid with small amount of blood.Review of the device history records identified no related deviations or anomalies during manufacturing.A definitive 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.
|