Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
No Code Available (3191); Metal Related Pathology (4530)
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Event Date 11/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: catalog number:1673488, lot number: 162032, brand name: bi-metric hap 12x140 mm, unknown ceramic head.Source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01993.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
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Event Description
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It was reported that the patient experienced elevated metal ions approximately 10 years post implantation.Patient has been added to a waiting list for revision surgery, however, no revision has been reported to date.Additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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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Manufacturer Narrative
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Supplemental report provided as additional information was made available to include explant date (d6b), event update (b5) and patient identifier (a1) as previously reported under mfr #0001825034-2020-01994.
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Event Description
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It was reported that the patient underwent a revision procedure approximately 12 years after implantation due to raised metal ions and an abnormal mri scan.No additional information is available at the time of this report.
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Event Description
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There is no update to the prior event description provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.The additional information does not change the outcome of the previous investigation.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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