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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Renal Failure (2041)
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Event Date 08/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 06655, 0001825034 - 2018 - 06656, 0001825034 - 2018 - 06657.Concomitant medical products: ep-107825, epoly lnier, lot 714980, 11-104060 m/h radial shell, lot 318980, ep-107825, epoly liner, lot 568720.Reported event was confirmed due to review of provided medical records and/or patient x-rays.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.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.Not returned to manufacturer.
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Event Description
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It was reported the patient had a two-stage revision to address infection with (b)(6) group g strep with renal failure complications.The devices were reimplanted.No further information has been made available.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records received.The patient presented with hip pain, acute severe cellulitis treated with antibiotics.Aspiration of hip joint revealed greater than 200,000 white blood cells with a significant shift and positive for group g strep, all indicative of infection.Upon incising the fascia, purulence was noted and had caused necrosis of the anterior repair with significant soft tissue loss.All components were removed, wound irrigated.Two cables were used to repair the bone from osteotomy.New components implanted with spacer.Hemovac drain placed.No further complications noted.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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Search Alerts/Recalls
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