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

Catalog Number	AR-513-BE14
Health Effect - Clinical Codes	Pain (1994); Increased Sensitivity (2065); Swelling (2091)
Date of Event	11/09/2016
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 implant has normal wear patterns on the articulating surface.Furthermore, damages were observed on the a,b, and c surface which were most likely caused during the extraction of the implant.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-503-pslf and lot number 108761213 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2014 a patient underwent a left tka procedure (during which time the patella was not resurfaced).On (b)(6) 2015 the patient underwent a left bearing exchange/patelloplasty procedure ((b)(4)).On (b)(6) 2016 the surgeon performed a left tka revision due to tibial loosening and patient pain.During the revision procedure the surgeon explanted the following components: tibial tray (b)(4), lot 108761203 ((b)(4)), femoral implant ar-503-pslf, lot 108761213 ((b)(4)), bearing implant ar-513-be14, lot 113601330a ((b)(4)) and patella implant ar-504-psd0, lot 113601415 ((b)(4)).To complete the procedure the surgeon used another manufacturer's product.Patient was a male, dob (b)(6) 1956.Patient medical records date (b)(6) 2016 noted: findings left knee x-ray showed prosthesis in place, in proper anatomical alignment, without rotation, loosening or stress shielding.Patient medical records dated (b)(6) 2016 noted: examination of the left knee demonstrates medial joint line tenderness and lateral joint line tenderness.Mild effusion of the left knee was noted.Patient was unstable to valgus stress at 30 degrees flexion.Records noted surgeon recommended a total knee due to pain in the knee that is increased with weight bearing/ patient had pain through a limited passive range of motion with crepitus and swelling.X-rays were noted to show periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA BEARING
• 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: 6142643
• Report Number: 1220246-2016-00540
• Device Sequence Number: 1075419
• Product Code: JWH
• UDI-Device Identifier: 00888867107298
• UDI-Public: 00888867107298
• 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
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

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: 06/01/2019
• Device Catalogue Number: AR-513-BE14
• Device Lot Number: 113601330A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/02/2016
• 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: 60 YR