MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA PATELLA IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-504-PSC9
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)
Date of Event	08/18/2016
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.This is the fourth of four submissions from the same patient event.The others are 1220246-2016-00376 ((b)(6)), 1220246-2016-00377 ((b)(6)) and 1220246-2016-00378 ((b)(6)).The device was not returned for evaluation and 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-504-psc9 and lot number 113601237 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 on (b)(6) 2013, a patient underwent a left tka procedure.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-ttte (lot 108761229)((b)(6)), femoral implant ar-503-pslf (lot 108761212) ((b)(6)), bearing implant ar-503-be12 (lot 113601237) ((b)(6)) and patella implant ar-504-psc9 (lot 113601237) ((b)(6)).To complete the procedure the surgeon used another manufacturer's product.Patient was a female, dob (b)(6) 1961.Medical records dated (b)(6) 2016 noted the following: patient having pain and a grinding sensation under kneecap when walking.Patient also noted the knee feels loose and unstable.Examination of the left knee with palpation demonstrated medial joint line and patellofemoral region tenderness but no lateral joint line tenderness.Trace effusion of the left knee was noted.Records noted patient has pain through a limited passive range of motion with crepitus and swelling.Medical records also noted x-rays showed periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA PATELLA IMPLANT
• 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: 5940749
• Report Number: 1220246-2016-00379
• Device Sequence Number: 16337027
• Product Code: JWH
• UDI-Device Identifier: 00888867035560
• UDI-Public: 00888867035560
• 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): 08/19/2016

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: 05/01/2018
• Device Catalogue Number: AR-504-PSC9
• Device Lot Number: 113601237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2016
• Initial Report FDA Received Date: 09/09/2016
• 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; Required Intervention
• Patient Age: 55 YR