Model Number N/A |
Device Problems
Degraded (1153); Patient Device Interaction Problem (4001)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 03/15/2022 |
Event Type
Injury
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Event Description
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It was reported that stem and head had to be removed due to metallosis and oxidation of the collar.
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Manufacturer Narrative
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This product is manufactured by zimmer biomet (b)(4).Ref and lot numbers are not available at the moment.The manufacturer did receive x-rays for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.The product will be sent back to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item: 01.00295.012; name: cls spotorno, stem, 125°; lot: 2526342.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00232.
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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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(b)(4).The manufacturer did not receive the device for investigation.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The following report is associated with this event: 0009613350-2022-00235.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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