Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.42532006402 tibia cemented 5 degree stemmed right size c lot# 65321784 mdr: 3007963827-2022-00236.
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Event Description
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It was reported that total knee arthroplasty was performed.Surgeon had a hard time to insert an articular surface in tibia plate.So, he pressed the articular surface to the tibia plate.At the same time, the tibial plate, which was fixed with cement, moved with the patient tibia bone.And the tibia cement fixation loosened.A second tibia was used to complete the procedure.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Articular surface was not returned.Visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were not provided.The complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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