Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 from the wir form that a persona knee instrument was returned and reported missing bearing.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Performed a visual inspection of the returned item and found it to exhibit signs of repeated use and has components disassembled /missing the components were not returned.The device history records & receiving inspection report were reviewed for deviations and/ or anomalies with no deviations/anomalies identified.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
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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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