Model Number N/A |
Device Problems
Insufficient Information (3190); Migration (4003)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical devices: unknown femoral catalog#: ni, lot#: ni.Unknown tibial insert catalog#: ni, lot#: ni.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the patient underwent a revision of the tibial tray for an unknown reason.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Event Description
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It was reported that the patient underwent a right knee revision approximately nine months post implantation due to tibial tray subsidence.Attempts to obtain additional information have been made; however, no more 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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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: radiolucency of the tibial component of right total knee arthroplasty, nonspecific but possibly related to loosening or subsidence.Device history record was reviewed and no discrepancies 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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