Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2023 |
Event Type
Injury
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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 the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : remians implanted.
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Event Description
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It was reported that the sales representative didn't have a baseplate in their kit for surgery.Another baseplate wouldn't be available for two (2) hours.Therefore, the surgeon elected to close up the patient's wound.The patient spent the night at the hospital and the procedure was completed the following day without complications.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4) reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to failure to follow instructions as per the safe surgery checklist by the world health organization and backed by aorn, it is the responsibility of the surgical team to ensure that all implants, instruments, and equipment are present and inspected as ready for use prior to patient entering the room and procedure start.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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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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