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

Catalog Number	AR-504-PSD0
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.During the revision due to patient pain, the surgeon chose to also remove this device.Per customer, the device will not be returned for evaluation.No more information has been made available by the customer.If arthrex receives further details from the customer, a follow-up submission will be made if necessary.A dhr review for this catalog number, ar-504-psd0 and lot number 113601415 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)(6)).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 ar-503-ttte, lot 108761203 ((b)(6)), femoral implant ar-503-pslf, lot 108761213 ((b)(6)), bearing implant ar-513-be14, lot 113601330a ((b)(6)) and patella implant ar-504-psd0, lot 113601415 ((b)(6)).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 PATELLA IMPLANT
• 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: 6142646
• Report Number: 1220246-2016-00541
• Device Sequence Number: 13721880
• Product Code: JWH
• UDI-Device Identifier: 00888867035577
• UDI-Public: 00888867035577
• 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: 05/01/2019
• Device Catalogue Number: AR-504-PSD0
• Device Lot Number: 113601415
• Was Device Available for Evaluation?: No
• 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