Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Scar Tissue (2060)
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Event Date 02/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products: vanguard xp tibial bearing left lateral #195814 lot #641500.Vanguard xp interlok femur #195216 lot #396200.Vanguard xp interlok pri tibial tray #195757 lot #273090.Study - gk9g declaire xp registry (504).Multiple mdr reports were filed for this event, please see associated reports: vanguard xp tibial bearing left lateral - 0001825034-2017-08110.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent a bearing revision and scar resection approximately 13 months post initial knee surgery.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are 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 underwent revision due to intra articular scar approximately 13 months post-implantation.Arthrotomy and poly exchange was performed.No further information has been provided.
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Search Alerts/Recalls
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