MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTJ
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Alteration In Body Temperature (2682)
Date of Event	10/26/2016
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 catalog number, ar-503-tttj and lot number 957056 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 bi-lateral tka procedure (during which time the patella was not resurfaced).On (b)(6) 2016 the surgeon performed a revision left tka due to patient pain.During the revision procedure, the surgeon explanted the tibial tray ar-503-tttj, lot 957056 ((b)(4)), femoral implant ar-503-pslj, lot 108761215 ((b)(4)) and bearing implant ar-503-bj15, lot 113601231 ((b)(4)).To complete the procedure, the surgeon used another manufacturer's product.Patient was a male, (b)(6).Patient medical records dated (b)(6) 2016 noted patient has persistent anterior left knee pain which was aggravated three weeks prior while stepping off a forklift at work.Records noted patient had been doing very well until the recent work injury.Examination of the left knee demonstrated warmth and swelling but no erythema.Palpation of the left knee demonstrated inferior pole patella tenderness and medial joint line tenderness, but no lateral joint line tenderness.Trace effusion of the left knee was noted.Rom examination of the left knee demonstrated patella-femoral crepitus with motion.Patient had a positive patella grind test.Records noted x-ray showed periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 8
• 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: 6117805
• Report Number: 1220246-2016-00516
• Device Sequence Number: 19019650
• 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: 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): 10/27/2016

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: 11/01/2018
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 957056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR