MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY, SIZE 8; PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/

Catalog Number	AR-513-T8
Health Effect - Clinical Codes	Joint Swelling (2356); Joint Disorder (2373)
Date of Event	11/28/2016
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 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-513-t8 and lot number 10019689 combination found no related information.Device expected but not yet returned.
Event or Problem Description
It was reported that patient underwent a left tka on (b)(6) 2014 during which the patella was not resurfaced.On (b)(6) 2016 patient had a left tka revision surgery ((b)(4)).During the 5/11/16 revision the original tka and bearing implant were explanted and the following arthrex devices were implanted: tibial tray, stem extension, bearing implant and patella implant.On (b)(6) 2016 the patient underwent a second left tka revision surgery due to a reported loose tibia and femur.The following parts were explanted during the (b)(6) 2016 procedure: tibial tray ar- 513-t8, lot 10019689 ((b)(4) (b)(6)), femoral implant ar-503-pslj, lot 108761211 ((b)(4) (b)(6)), stem extension ar-513-1250, lot 10018106 ((b)(4) (b)(6)), tibial bearing ar-513-bj18, lot 113601327 ((b)(4) (b)(6)) and patella implant ar-504-psc9, lot 113601511 ((b)(4) (b)(6)).To complete the revision the surgeon used another manufacturer's products.Patient is a male, age (b)(6), dob (b)(6) 1957.Patient medical records dated 5/27/16 noted: x-rays showed no acute fracture, no acute dislocation, no loose bodies noted, prosthesis in good place in proper anatomical alignment without rotation, loosening or stress shielding and hardware noted in acceptable position.Patient medical records dated 9/21/16 noted: patient reported his patella is jumping out of place and stated he noticed this 4 weeks after his 5/11/16 surgery.Examination of the left knee demonstrated swelling and well healed surgical incision but no erythema and no ecchymosis.Palpation of the left knee demonstrated patellofemoral region tenderness but no medial joint line or lateral joint line tenderness.Trace effusion of the left knee was noted.Records also noted that patient x-rays show periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY, SIZE 8
• 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: 6184886
• Report Number: 1220246-2016-00566
• Device Sequence Number: 82335
• Product Code: JWH
• UDI-Device Identifier: 00888867106703
• UDI-Public: 00888867106703
• 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: 2016
• 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): 12/19/2016

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: 12/12/2020
• Device Catalogue Number: AR-513-T8
• Device Lot Number: 10019689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/19/2016
• 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-504-PSC9, IBALANCE PATELLA IMPL, LOT 113601511; AR-513-1250, IBALANCE TKA TIB STEM, LOT 10018106; AR-513-BJ18, IBALANCE TKA BEARING, LOT 113601327
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR