EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 1 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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Model Number TRULIANT TIB IMP PS INSERT SZ 1 12MM |
Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/12/2020 |
Event Type
Injury
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Event Description
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As reported by the exactech cc clinical study, approximately three months post initial left side tka, the 63 y/o female patient experienced tibial implant subsidence and incomplete fixation of femoral component, progressive pain and functional compromise.Patient had a revision on (b)(6) 2020 of femoral, tibial insert, tibial tray components.
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Manufacturer Narrative
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Concomitant products: logic cc femoral size 1, left (cat# 02-010-06-0210 / serial# (b)(4)).Logic stem ext 14mm x 25mm (cat# 02-012-60-1425 / serial# (b)(4)).Logic offset stem ext coupler 4mm (cat# 02-012-61-4000 / serial# (b)(4)).Tru fluted stm ext 12mm x 80mm blast (cat# 02-012-64-1280 / serial# (b)(4)).Cc distal fem augment sz 1, 5mm (cat# 208-05-01 / serial# (b)(4)).Truliant tib imp ps insert sz 1 12mm (cat# 02-022-35-1012 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Search Alerts/Recalls
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