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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Remains implanted.
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Event Description
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It was reported that the patient underwent an initial knee arthroplasty on an unknown date.Subsequently, the patient suffered from a non-displaced tibial plateau fracture three weeks post-operatively, which was treated conservatively and healed.All three pins were used.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).(udi): (b)(4).Concomitant medical products : catalog #: 42558000401, partial femur cemented size 4 left medial, lot # 63690624, catalog #: 42518200609, partial articular surface left medial size f, lot # 63707716.Reported event is considered confirmed as a review of the x-ray showed that there was a vertical radiolucent fracture that is present on the tibial component.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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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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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