MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-504-PSC9
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/25/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 113601223 combination found no related information.H3 other text : unknown device disposition.
Event or Problem Description
It was reported that on (b)(6) 2013 a patient underwent a bi-lateral tka procedure.On (b)(6) 2013 due to right patellar subluxation, chronic effusion and mid-flexion laxity status the patient had a right knee proximal realignment patella subluxation patelloplasty during which the following devices were explanted: bearing implant ar-503-bh12, lot 113601221 and patella implant ar-504-psc9, lot 113601223.To complete the procedure the surgeon implanted the following arthrex products: bearing implant ar-503-bh18, lot 113601222 and patella implant ar-504-psd0, lot 113601237.Patient is a male and was (b)(6)years of age at time of procedure.Dob (b)(6) 1953.Medical records indicate patient has a bmi of 35 which is in the obese range and is contraindicated for this product.

• Brand Name: IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
• 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: 6587308
• Report Number: 1220246-2017-00195
• Device Sequence Number: 1279406
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

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: 09/01/2017
• Device Catalogue Number: AR-504-PSC9
• Device Lot Number: 113601223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/24/2017
• 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-503BH12, BEARING IMPLANT, LOT 113601221
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR