MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTG
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2016
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 contribution of the device to the reported event could not be determined.The information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-503-tttg and lot number, 108761208 combination found no related information if additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that patient underwent a bi-lateral tka procedure on (b)(6) 2014.Due to a loose tibia and femur the patient underwent a revision right tka procedure on (b)(6) 2016.During the revision procedure the surgeon explanted the following arthrex products: tibial tray ar-503-tttg (lot 108761208 ) ((b)(4)), femoral implant ar-503-psrh (lot 108761219) ((b)(4)), bearing implant ar-503-bg15 (lot 113601227 ) ((b)(4)) and patella implant ar-504-psc9 (lot 108601324) ((b)(4)).The revision was completed using another manufacturer's product.Patient was a male, dob (b)(6) 1964.Patient medical records dated (b)(6) 2016 noted patient has had chronic knee pain.Examination of the right with palpation demonstrated medial joint line tenderness and lateral joint line tenderness (diffuse tenderness throughout the knee, hypersensitivity to light touch) with trace effusion of the right knee.Records noted that right knee x-ray showed prosthesis in place with mild lucency around the tibial component.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 6
• 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: 5930768
• Report Number: 1220246-2016-00368
• Device Sequence Number: 13656707
• Product Code: JWH
• UDI-Device Identifier: 00888867106741
• UDI-Public: 00888867106741
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2016

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: 12/01/2017
• Device Catalogue Number: AR-503-TTTG
• Device Lot Number: 108761208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2016
• Initial Report FDA Received Date: 09/06/2016
• 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-BG15, IBALANCE TKA BEARING, LOT 113601227; AR-503-PSRH, IBALANCE TKA, FEMORAL, LOT 108761219; AR-504-PSC9, IBALANCE PATELLA, LOT 113601324
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 52 YR