MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 3
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation revealed the returned device's critical mating feature (top surface a that mates with the poly bearing) are within specifications.The damages observed on the surfaces a and b, as well as the sides of the device were most likely caused during the extraction of the implant.
Event or Problem Description
It was reported by the sales rep that a revision total knee procedure took place on (b)(6) 2021.The reason for the revision was due to tibial loosening.The following arthrex products were explanted during this surgery ar-5030pslf, lot: 108761213; ar-503-tttd, lot: 108761149; ar-503-bd08, lot: 113601218.Once the devices were explanted, the surgeon performed a metacta hinged total knee procedure.The sales rep reported that they cannot confirm the part and lot numbers of the arthrex product implanted during the revision surgery.The sales rep stated that the procedure was successful without any product malfunctions.The primary procedure took place on (b)(6) 2013.The sales rep reported that it cannot be confirmed the place where the primary procedure was performed.The primary procedure was performed by a different surgeon.The explanted arthrex devices will be returned for evaluation.
Additional Manufacturer Narrative
The evaluation revealed the returned device's critical mating feature (top surface a that mates with the poly bearing) are within specifications.The damages observed on the surfaces a and b, as well as the sides of the device were most likely caused during the extraction of the implant.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11398479
• Report Number: 1220246-2021-02667
• Device Sequence Number: 13773823
• Product Code: JWH
• UDI-Device Identifier: 00888867106710
• UDI-Public: 00888867106710
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K081227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 3
• Device Catalogue Number: AR-503-TTTD
• Device Lot Number: 108761149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-503-BD08,IBAL TKA BEARING IMPL,PS,SZ 3,8MM; AR-503-PSLF, IBAL TKA FEM,PS SZ 5,LFT,CEMENTED; AR-503-BD08,IBAL TKA BEARING IMPL,PS,SZ 3,8MM; AR-503-PSLF, IBAL TKA FEM,PS SZ 5,LFT,CEMENTED
• Outcome Attributed to Adverse Event: Other