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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Fall (1848); Failure of Implant (1924)
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Event Date 11/30/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a left knee arthroplasty revision to address instability approximately seven (7) years post-operatively following a fall.Attempts have been made, however, no additional information is available.
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Manufacturer Narrative
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(b)(4).D10 - concomitant devices - nexgen porous uncemented femoral component size g left catalog #: 65595201701 lot #: 62732439, nexgen stemmed precoat tibial component size 5 catalog #: 00598004701 lot #: 62772516, nexgen all poly patella size 35mm catalog #: 00597206535 lot #: 62785917.G2 - report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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 patient; please see all reports associated with this event: 0001822565-2023-02661.H3 other text : investigation incomplete.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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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Search Alerts/Recalls
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