Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problem
Erosion (1750)
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Event Date 05/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2019 -02251, 0001822565 -2019 -02252.0001822565 -2019 -02253.Device discarded.
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Event Description
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It was reported that the patient was transferred from another center.The znn lag screw starting to cut out of the femoral head.After examining the extent of bone loss in proximal femur, it was decided to perform a total hip arthroplasty.Nail was explanted using znn and its instruments.Surgery was completed with another cpt stem with no delay in the procedure.Attempts have been made and no further information has been provided.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause could not be determined.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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