MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 7
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
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-ttth and lot number 1358298 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 on (b)(6) 2015 that the patient underwent a left tka procedure.On (b)(6) 2018 the surgeon performed a left tibial component revision arthroplasty, tibial augment, stem extension procedure due to mechanical loosening of the tibial tray.During the revision procedure the surgeon explanted the arthrex tibial tray ar-503-ttth (lot 1358298) and arthrex bearing ar-513-bh12 (lot 113601341).Thereafter, the surgeon implanted the following arthrex ibalance devices: modular tibial tray (lot 10141889), stem extension (lot 10024349), tibial augment with locking screw (lot 10017209) and bearing(lot 113601336).(the specific catalog numbers and sizes of the new implants are unknown).According to the revision operative report, the femoral and patellar components were well fixed and appeared in excellent condition.The tibial component was grossly loose and was easily removed from the patient.The surgeon noted that the cement was completely debonded from the undersurface of the component.The cement remained well fixed to the tibial bone.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 7
• 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: 8348075
• Report Number: 1220246-2019-00906
• Device Sequence Number: 16194585
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/18/2019

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 Model Number: IBALANCE TKA TIBIAL TRAY SIZE 7
• Device Catalogue Number: AR-503-TTTH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/18/2019
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-1/29/16-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR