Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994)
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Event Date 12/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Additional concomitant medical products: unknown vangaurd tibial component catalog # unknown lot # unknown; unknown vangaurd articular surface catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. multiple mdr reports were filled for this event: 0001825034-2018-00276, 0001825034-2018-00277.Remains implanted.
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Event Description
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It is reported that the patient underwent a knee arthroplasty.Subsequently, the patient required injections to treat post-operative pain.
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Manufacturer Narrative
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The follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Concomitant medical products: 195909, vgxp intlk femoral rt 62.5, 029390; 195772, vgxp xp e1 tib brg rl 9x63, 526870; 195842, vgxp xp e1 tib brg rm 9x63, 335190.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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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It was reported that the patient experienced a fracture of the anterior bony island on an unknown date that required re-fixation using ethibond.
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Manufacturer Narrative
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The follow-up report is being submitted to relay additional information.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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