Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Fall (1848); Pain (1994); No Information (3190)
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Event Date 06/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: kne-unknown-tibial- mdr: 0001825034-2021-00268.Kne-unknown-femoral- mdr: 0001825034-2021-00269.Kne-unknown-patella- mdr: 0001825034-2021-00271.
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Event Description
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It was reported by the pmi group that a patient underwent a left knee arthroplasty.Subsequently, approximately 6 months post procedure the patient is being considered for a pmi product on an unknown day for an unknown reason.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Radiographs were provided and x-ray evaluation by third party healthcare professional confirms that the locking screw was displaced.Review of the available radiographs identified the following: knee alignment is maintained with no fracture; the poly locking screw is displaced and extends into the knee joint; bone quality is osteopenic.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
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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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Search Alerts/Recalls
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