ARTHREX, INC. PS TIBIAL BEARING, SIZE 3, 14MM, VIT E; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number IBAL TKA,BEARING IMP,PS,SZ 3,18MM |
Device Problems
Loose or Intermittent Connection (1371); Unstable Capture Threshold (3269)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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Complaint confirmed.The returned implant showed signs of wear on the posterior side, inferior and superior surfaces, as well as damage to the locking mechanism on the posterior side.The visible damage suggests the most likely cause of failure is a posterior to anterior event with a force greater than or equal to what would typically cause the tibial bearing to fail.
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Event Description
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It was reported that a patient had a total knee procedure on (b)(6) 2018.Roughly one and a half years after implantation the ar-523-b314 (lot: 115571546) tibial bearing came loose from the tibial tray, and the knee became unstable.The following arthrex parts were used during the primary procedure: ar-523-b314 // lot: 115571546 // qty.: 1.Ar-524-psc9 // lot: 132581730 // qty.: 1.Ar-513-t3 // lot: 10167303 // qty.: 1.Ar-516-5r // lot: 10183110 // qty.: 1.A bearing exchange procedure took place on (b)(6) 2019.During the revision procedure the surgeon explanted the ar-523-b314 (lot: 115571546), and implanted ar-513-bd18 (lot: 113601819).The rep reported the poly was the only arthrex device explanted during the revision procedure.The primary right tka and the bearing exchange procedure were performed by the same surgeon.The explanted device has been returned to arthrex.
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