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 Codes	Pain (1994); No Code Available (3191)
Date of Event	08/01/2016
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-ttth and lot number 984546 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 on (b)(6) 2014 a patient underwent a left tka procedure.On (b)(6) 2016 the surgeon performed a revision left tka reportedly due to loose femur and tibia.During the revision procedure the surgeon explanted the tibial tray ar-503-ttth (lot 984546 ) ((b)(4)), femoral implant ar-503-pslh (lot 108761213) ((b)(4)), and bearing implant ar-503-bh12 (lot 77941245) ((b)(4)).To complete the procedure the surgeon used another manufacturer's product.Patient was a male, dob (b)(6).Patient medical records dated (b)(6) 2016 noted patient continues to have increased pain.Examination of the left knee with palpation demonstrates medial joint line tenderness and patellofemoral region tenderness but no lateral joint line tenderness.Mild effusion of the left knee noted.Knee demonstrated mild retropatellar crepitus with motion.

• 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: 5911765
• Report Number: 1220246-2016-00357
• Device Sequence Number: 10863869
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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: 12/01/2018
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 984546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/29/2016
• 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: 54 YR