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 Code	Pain (1994)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The catalog number, ar-503-tttd and lot number 1191337 associated with this event has been involved in recall number 1220246-1/29/16-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.
Event or Problem Description
It was reported that the patient had a bi-lateral tka procedure (b)(6) 2014 during which time the patella was not resurfaced.On (b)(6) 2019 the patient underwent a revision left tka by the same surgeon.The revision was done because the patient x-rays were reported to show tibial subsidence causing chronic pain.The revision was completed by using another manufacturer's product.The following are the arthrex products which were originally implanted during the 2014 procedure.Each of these products were explanted on (b)(6) 2019: ar-503-tttd tibial tray implant (lot 1191337), ar-503-psle femoral implant (lot 108761324), ar-503-bd12 bearing implant (lot 113601234).
Additional Manufacturer Narrative
The evaluation revealed the returned device's critical mating feature (top surface that mates with the poly bearing) are within specifications.The marks observed on the surface were most likely caused by the extraction of the implant.The damage to the bottom surface was likely caused by the removal process and subsequent handling.The catalog number, ar-503-tttd and lot number 1191337 associated with this event has been involved in recall number 1220246-1/29/16-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.

• 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: 9141203
• Report Number: 1220246-2019-01333
• Device Sequence Number: 1840411
• Product Code: JWH
• UDI-Device Identifier: 00888867106710
• UDI-Public: 00888867106710
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 3
• Device Catalogue Number: AR-503-TTTD
• Device Lot Number: 1191337
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-1/29/16-001-R.
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-503-BD12 BEARING IMPLANT LOT 113601234.; AR-503-PSLE FEMORAL IMPLANT LOT 108761324.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR