Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.- manufacture date ¿ ni.There are warnings in the package insert that state that this type of event can occur: under precautions, "intraoperative fracture or breaking of instruments has been reported." device requested, not yet received.
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Event Description
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During an initial total hip arthroplasty, the threaded inserter shaft fractured as the liner was being impacted.The liner was fully seated.There was no delay in procedure and no foreign bodies were retained in the patient.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Product was sent to zb warsaw.The product couldn't be located within the facility.Therefore the condition of the device is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Search Alerts/Recalls
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