ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROV. RIGHT SIZE CD; INSTRUMENT, KNEE
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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 during a knee procedure, provisionals fractured after the surgeon used a mallet to impact the trial into the joint space.No adverse events have been reported as a result of the malfunction.
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Search Alerts/Recalls
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