MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 4
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2017
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 catalog number, ar-503-ttte and lot number 1315454 associated with this event has been involved in recall number 1220246-1/29/16-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.
Event or Problem Description
It was reported via the patient's legal representative that the patient underwent a right total knee arthroplasty procedure on (b)(6) 2015.During the 2015 procedure the following arthrex products were implanted: ar-503-ttte tibial tray implant (lot 1315454), ar-517-5r femoral implant (lot 1438474), ar-503-a409 bearing implant (lot 113601322), ar-504-psb8 patella implant (lot 113601439).It was reported that patient failed to respond to conservative treatment, was experiencing persistent pain and had a bone scan that demonstrated loosening of the tibial component.As a result, the patient underwent a revision right total knee arthroplasty with a stemmed tibial component on (b)(6) 2017.The (b)(6) 2017 operative report noted that the femoral component was well fixed as was the patellar component.The tibial component was removed with the combination of a gigli saw and an oscillating motorized saw and was noted to be loose.The revision was completed using a stemmed tibial component.Both procedures were performed by the same surgeon at the same facility.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 4
• 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: 8903017
• Report Number: 1220246-2019-01252
• Device Sequence Number: 2267388
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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: 06/30/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 4
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1315454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR