MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 3, 14MM, VIT E; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	IBAL TKA,BEARING IMP,PS,SZ 3,18MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: PS TIBIAL BEARING, SIZE 3, 14MM, VIT E
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9214786
• Report Number: 1220246-2019-01366
• Device Sequence Number: 2524286
• Product Code: MBH
• UDI-Device Identifier: 00888867232402
• UDI-Public: 00888867232402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 05/31/2023
• Device Model Number: IBAL TKA,BEARING IMP,PS,SZ 3,18MM
• Device Catalogue Number: AR-523-B314
• Device Lot Number: 113601819
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other