Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Pain (1994)
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Event Date 12/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: articular surface medial congruent (mc) left 10 mm height use with tibia sizes e-f/cr femur sizes 6-7 catalog#: 42512100710 lot#: 63175219, all poly patella standard size 38 mm diameter 9.5 mm thickness cemented catalog#: 00597206538 lot#: 64209115, femur cemented cruciate retaining (cr) standard left size 9 catalog#: 42502606601 lot#: 63992838.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.
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Event Description
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It was reported that patient underwent a revision procedure approximately eight months post-implantation due to a 0.8 degree tibial subsidence.Attempts to obtain additional information have been made; however, no more is available.
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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 medical records.Medical records were provided and reviewed by a health care professional.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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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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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