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

Device Problems Loose or Intermittent Connection (1371); Unstable Capture Threshold (3269)

Patient Problem Failure of Implant (1924)

Event Date 09/16/2019

Event Type  Injury  

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 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
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9214786
• MDR Text Key: 163360073
• Report Number: 1220246-2019-01366
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00888867232402
• UDI-Public: 00888867232402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other