Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical device: tibia cemented 5 degree stemmed right size f, catalog #: 42532007502, lot #: 65303816.Product has been received by zimmer biomet and 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 the articular surface would not lock into the tibia and staff had to open a second articular surface.The surgical technique was utilized.There was no surgical delay.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product/ provided pictures shows that the dovetail feature is compressed and flared.Additionally, the distal surface was damaged with nicks and gouges.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in persona- the personalized knee surgical technique.The root cause is attributed to use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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