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

Catalog Number	AR-503-TTTC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/23/2016
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.
Event or Problem Description
It was reported that on (b)(6) 2013 a patient underwent a right tka procedure.On (b)(6) 2016 surgeon performed a revision right tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-tttc lot 108761313, ((b)(4) (b)(6)) and bearing implant ar-503-bc12 lot 113601233 ((b)(4) (b)(6)).To complete the procedure the surgeon used tibial tray ar-513-t3, lot 1002043 and bearing implant, ar-513-bd20 lot 113601351.Patient was a female, age (b)(6), dob (b)(6) 1944.Patient medical records dated (b)(6) 2015 noted: x-rays of the right knee showed hypertrophic bone formation, native patella, but prosthesis in place in proper anatomical alignment without rotation, loosening, or stress shielding.Patient medical records date (b)(6) 2016 noted: examination of right knee showed no visible abnormalities.Palpation of the right knee demonstrated medial joint line tenderness and medial tibial plateau tenderness.It was noted there was no effusion of the right knee.Records noted the patient bone scan findings as follows: impression-moderate uptake within the b/l knees prosthesis.Right knee greater than left.

• Brand Name: IBALANCE TKA TIBIAL TRAY, SIZE 2
• 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: 6184842
• Report Number: 1220246-2016-00565
• Device Sequence Number: 1004116
• 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: 2013
• 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): 12/19/2016

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: 09/01/2018
• Device Catalogue Number: AR-503-TTTC
• Device Lot Number: 108761313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/19/2016
• 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-BC12, IBALANCE TKA BEARING, LOT 113601233
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR