Model Number N/A |
Device Problems
Device Slipped (1584); Patient-Device Incompatibility (2682)
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Patient Problems
Toxicity (2333); Reaction (2414)
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Event Date 07/17/2015 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 4 states, "loosening, migration, or fracture of the implants can occur." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04024 / 04025).
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Event Description
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It was reported that patient underwent a total right knee anthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2015 due to loosening caused by a possible metal allergy.All components were removed and replaced by titanium components.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and/or allergic reaction.¿.
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Event Description
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It was reported that patient underwent a revision procedure approximately 20 months post-implantation due to tibial loosening from a possible metal allergy.Both the femoral component and tibial tray were removed and replaced with titanium components.
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Search Alerts/Recalls
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