MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTF
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	08/29/2016
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 device's critical mating features on surface a (surface that mates with the bearing) are within specification.The damages observed on the surfaces 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-tttf and lot number 108761230 combination found no related information.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2014 a patient underwent a left tka procedure.On (b)(6) 2016 the surgeon performed a revision left tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-tttf lot 108761230 ((b)(4)), bearing implant ar-503-bf12 lot 113601227 ((b)(4)) and patella implant ar-504-psc9 lot 113601324 ((b)(4)).To complete the procedure the surgeon implanted the following arthrex parts: tibial tray ar-513-t5 lot 10029414, bearing implant ar-513-bf20 lot 113601335, stem extension implant ar-513-1450 lot 10036355 and patella implant ar-504-psc9 lot 113601548.Patient was a female, (b)(6).Patient medical records date (b)(6) 2016 noted the following: x-ray findings of the left knee showed prosthesis in place in proper anatomical alignment without rotation, loosening, or stress shielding and hardware was noted in acceptable position.Patient medical records dated (b)(6) 2016 noted the following: approximately 1 year post op (b)(6) 2014 left tka patient began to notice progressing return of pain with no reported injury.Patient reported swelling as well to the point of feeling close to pre-op (b)(6) 2014 status.Examination of the left knee demonstrated swelling.Palpation demonstrated inferior pole patella tenderness with no tenderness superior pole patella, lateral joint line or tibial tubercle.Mild effusion of the left knee was noted.Crepitus with motion and pain with flexion were noted.Records indicated a positive appley's compression test and a positive patella grind test, negative patella apprehension test and negative dial test.The (b)(6) 2016 records noted that x-ray showed periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 5
• 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: 5966076
• Report Number: 1220246-2016-00394
• Device Sequence Number: 10938929
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• 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): 08/30/2016

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: 01/01/2018
• Device Catalogue Number: AR-503-TTTF
• Device Lot Number: 108761230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2016
• Initial Report FDA Received Date: 09/21/2016
• 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-503-BF12, IBALANCE TKA BEARING, LOT 113601227; AR-504-PSC(, IBALANCE PATELLA IMPLANT, LOT 1136013
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR