Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problem
No Code Available (3191)
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Event Date 10/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not 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: 0001825034-2018-11536.
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Event Description
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It was reported patient underwent hip revision approximately 9 years post implantation due to patient allegations of metal on metal.During the procedure, the modular head component was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed with operative notes.Revision operative notes demonstrated that the patient was revised due to elevated metal ion levels.During the surgery, trunnionosis was found between the head and stem.New ceramic head and dual mobility bearing were implanted.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot 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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