Model Number N/A |
Device Problems
Difficult or Delayed Positioning (1157); Defective Device (2588)
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Patient Problem
No Information (3190)
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Event Date 12/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that during a left total knee arthroplasty, the implant was not locking properly with the mating device.It was discovered that the implant was defective.Another device was used to complete the surgery.Attempt for further information has been made, but no further information has been provided.
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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.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of compressed and flared dovetail feature.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause is related to the surgical technique.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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