Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Failure of Implant (1924); Local Reaction (2035); Metal Related Pathology (4530)
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Event Date 08/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is unknown at this time if the device will be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001822565-2021-00900.
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Event Description
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It was reported that the patient underwent a revision procedure due to elevated cobalt levels, significant soft tissue extension and metallosis.They have significant findings of cystic degenerative changes inclusive of around the psoas and soft tissue thickening in the capsule and pericapsular tissues.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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to 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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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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