Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2022 |
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 that during a left hip procedure a hole was discovered in the sterile packaging and the implant was sticking out.There was no direct contact with the patient.A new stem was used to complete the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Evaluation of the returned product confirmed there is: white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Debris inside the sterile packaging which is consistent with the appearance of porous coating.Damage to the sterile packaging (blister and pouch).Sterility has been compromised.Damage to the inside of the outer carton.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.A summary of the investigation was sent to the customer.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 additional event information to report at this time.
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Search Alerts/Recalls
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