Model Number 1294-54-120 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Synovitis (2094); Injury (2348); No Code Available (3191)
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Event Date 05/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Clinical adverse event received for loosening of both femoral and tibial components: abnormal radiographic evaluation.Event is serious and is considered moderate.Event is definitely related to device and possibly related to procedure.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
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Search Alerts/Recalls
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