Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00801803602-femoral head sterile product 12/14 taper-61123342.00620205822-shell porous with cluster holes 58 mm-61132723.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00233.0001822565 - 2020 - 01429.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
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Event Description
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It was reported the patient is being indicated for a revision surgery 11 years post implantation due to unknown reasons.A revision has not been reported.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 additional information on reported event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.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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Search Alerts/Recalls
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