MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTC
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.The evaluation revealed that the returned device's critical mating features on surface a (surface that mates with the bearing) are within specification.The damages observed on the surfaces were most likely caused during the extraction of the implant.The catalog number, ar-503-tttc and lot number 1227388 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 a patient had a left tka procedure on (b)(6) 2015.Due to tibial loosening the surgeon performed a revision left tka on (b)(6) 2016.During the revision the surgeon explanted the following original implants: tibial tray, ar-503-tttc lot 1227388 ((b)(4)).Femoral implant, ar-516-3l lot 108761422 ((b)(4)) and bearing implant, ar-513-bc16 lot 113601343 ((b)(4)).The arthrex patella implant, ar-504-psb8 lot 113601446 was not explanted.The revision procedure was completed using another manufacturer's product.Female patient, (b)(6).Patient medical records dated (b)(6) 2016 noted patient has pain in the left knee that is increased with activity and weight bearing.Records also noted patient had interference with activities of daily living and pain through a limited passive range of motion with crepitus and swelling.Records noted x-rays show periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 2
• 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: 6060990
• Report Number: 1220246-2016-00451
• Device Sequence Number: 775647
• Product Code: JWH
• UDI-Device Identifier: 00888867106703
• UDI-Public: 00888867106703
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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: 04/01/2019
• Device Catalogue Number: AR-503-TTTC
• Device Lot Number: 1227388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 10/27/2016
• 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-513-BC16, IBALANCE TKA BEARING, LOT 113601343; AR-516-3L, IBALANCE TKA FEMORAL, LOT 108761422
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR