Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Loss of Range of Motion (2032)
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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 remains implanted.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 a patient showed a limitation of range of motion (rom) which was probably related to the procedure and resulted to a device removal which was mentioned in the operation protocol.The placement of the plate was forced by the fracture pattern.There was no other way to sufficiently fix the bone fragments.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 (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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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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