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Model Number N/A |
Device Problems
Material Erosion (1214); Unstable (1667)
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Patient Problems
Pain (1994); Swelling (2091); Synovitis (2094); Reaction (2414)
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Event Date 05/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: articular surface with hinge post extension screw enclosed do not discard size f 12 mm height, femoral component for cemented use only size f left catalog 00588001601 lot 61871353, all poly patella size 32 mm dia.Standard 8.5 mm thickness catalog 00597206532 lot 62034479.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: 0001822565-2019-02444, 0001822565-2019-02445, 0001822565-2019-02446.
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Event Description
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It was reported that the patient underwent a revision procedure approximately seven years post implantation due to swelling, pain, elevated levels of co and cr in his blood after which the knee was judged as unstable.During the revision thick gray/ black fluid was noted; the surgeon noted that hypermobility may have caused stress on the hinge possibly contributing to the patient's high cobolt chromium levels.The articular surface, hinge pin, and tibial bushing were removed and replaced.
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Event Description
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Additional information received.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records.X-ray review showed slight angulated orientation of the hinge upon the tibial plate in the ap view suggesting the hinge mechanism has failed.The knee is positioned in slight valgus orientation, with angulation greatest at the level of the hinge.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information reported.
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Search Alerts/Recalls
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