Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 11/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant devices - persona partial knee cemented femoral component size 4 left medial catalog #: 42558000401 lot #: ni, persona partial articular surface left medial size e 9mm catalog #: 42518200509 lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the product will 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 patient; please see all reports associated with this event: 0001825034-2021-00689.Investigation incomplete.
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Event Description
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It was reported that the patient underwent a knee arthroplasty revision to address aseptic femoral and tibial loosening and pain approximately two (2) years post-operatively.Attempts have been made, however, no additional information is available at this time.
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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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The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.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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