MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA FEM IMP PS,CEMENTED SZ 7 RGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-516-7R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/02/2017
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-516-7r and lot number 108761338 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2015 a patient had a right tka procedure.A new surgeon performed a revision tka on (b)(6) 2016.Pre-operative diagnosis was malalignment of the femoral component of the right total knee replacement with recurring instability and dislocation of the right patella and patellar component.Revision operative report noted that patella was chronically dislocated on x-ray and the femoral component was fixed in 10 degrees of valgus which also predisposed patient for dislocate ability of the patellar bone and extensor mechanism.The tibial component was noted to be well fixed and aligned.During the revision procedure the following arthrex products were explanted: tibial tray ar-503-ttth, lot 1206181, femoral implant ar-516-7r, lot 108761338, bearing implant ar-513-bh12, lot 113601409 and patella implant ar-504-psc9, lot 113601437.Medical records indicate patient has a bmi of (b)(6) which is in the obese range and is contraindicated for this product.

• Brand Name: IBAL TKA FEM IMP PS,CEMENTED SZ 7 RGHT
• 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: 6584636
• Report Number: 1220246-2017-00197
• Device Sequence Number: 18971675
• Product Code: JWH
• UDI-Device Identifier: 00888867106765
• UDI-Public: 00888867106765
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• 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: 04/01/2019
• Device Catalogue Number: AR-516-7R
• Device Lot Number: 108761338
• 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: 05/23/2017
• 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-503-TTTH, TIBIAL TRAY, LOT 1206181; AR-504-PSC9, PATELLA IMLANT, LOT 113601437; AR-513-BH12, BEARING IMPLANT, LOT 113601409
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR