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	Pain (1994)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested but was not yet 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 1337240 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 that the patient had undergone a right tka procedure on (b)(6) 2015.During the original procedure the patella was resurfaced.The patient was experiencing pain and underwent a revision right tka procedure on (b)(6) 2019.The revision procedure was completed by implanting another manufacturer's product.During the revision the following arthrex products were explanted: tibial tray implant, ar-503-ttth, lot 1337240, femoral implant, ar-516-7r, lot 108761331, bearing implant, ar-513-bh12, lot 113601409, patella implant, ar-504-psc9, lot 113601430.
Additional Manufacturer Narrative
The evaluation revealed the returned device's critical mating feature (top surface that mates with the poly bearing) are within specifications.The marks observed on the surface were most likely caused by the extraction of the implant.The damage to the bottom surface was likely caused by the removal process and subsequent handling.The catalog number ar-503-ttth and lot number 1337240 associated with this event has been involved in recall number 1220246-1/298/16-001-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.

• 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: 9207322
• Report Number: 1220246-2019-01362
• Device Sequence Number: 14050548
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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 7
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 1337240
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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: 64 YR