MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via patient legal representative that on (b)(6) 2016 the patient had undergone a right total knee replacement procedure.The patient was later diagnosed with failed right total knee arthroplasty secondary to loosening and the patient underwent a revision right total knee arthroplasty on (b)(6) 2018 at a different facility by a different surgeon.Although the diagnosis mentioned loosening, there was no mention in the revision op report noting that any loosening was found.The patient's medical records also note that the patient is morbidly obese (bmi 42+ pre and post surgery) which is contraindicated for this device.During the revision procedure the following arthrex implants were removed: ar-513-t4 tibial tray (lot 10057043), ar-516-6r femoral implant (lot 1578051), ar-5623-b410 bearing implant (lot 115571546) and ar-504-psc9 patella implant (lot 132581609).The revision procedure was completed using another manufacturer's products.

• Brand Name: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
• 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: 8001597
• Report Number: 1220246-2018-00712
• Device Sequence Number: 11090562
• Product Code: MBH
• UDI-Device Identifier: 00888867187870
• UDI-Public: 00888867187870
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K152252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 07/31/2021
• Device Model Number: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
• Device Catalogue Number: AR-513-T4
• Device Lot Number: 10057043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/24/2018
• 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
• Patient Age: 49 YR
• Patient Weight: 112