MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY, SIZE 7; PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/

Catalog Number	AR-503-TTTH
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2016
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 information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-503-ttth and lot number, 108761152 combination found no related information.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.
Event or Problem Description
It was reported that on(b)(6) 2015 a patient underwent a right tka procedure.On (b)(6) 2016 the surgeon performed a revision right tka procedure due to patient pain.During the revision procedure the surgeon explanted the tibial tray ar-503-ttth , lot 108761152 (cc98983 line 174080), femoral implant ar-516-7r, lot 108761338 (cc98983 line 174081), bearing implant ar-513-bh11, lot 113601408 (cc98983 line 174082) and patella implant ar-504-psd0, lot 113601430 (cc98983 line 174083).To complete the procedure the surgeon used another manufacturer's product.Patient was a male, dob (b)(6).Patient medical records date (b)(6) 2016 noted: examination of the right knee demonstrated no erythema and no ecchymosis.Palpation of the right knee demonstrated inferior patella pole tenderness, medial joint line tenderness, lateral joint line tenderness and medial tibial plateau tenderness.Trace effusion of the right knee was noted.Records noted patient had pain through a limited passive range of motion with crepitus and swelling.X-rays were noted to show periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY, SIZE 7
• Common Device Name: PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6117785
• Report Number: 1220246-2016-00498
• Device Sequence Number: 18930860
• 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
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: 01/01/2018
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 108761152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/21/2016
• 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: 46 YR