Model Number N/A |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, the surgeon alleged that the articular surface didn't neatly mate with the tibial tray even though there was no third-party interference.There is no additional information available.
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Manufacturer Narrative
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(b)(4).G2- japan.H3- customer has indicated that the product will 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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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.Visual examination of the returned product identified the distal surface as damaged with nicks and gouges.Additionally, some of the dovetail features were flared.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.The complaint is confirmed via product evaluation.If any further information is received 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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