MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM; - PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that on (b)(6) 2015 the patient had undergone a bi-lateral tka procedure.On (b)(6) 2019 the patient underwent a revision right tka procedure due to pain and tibial loosening.During the revision procedure the following original arthrex implant devices were explanted: ar-503-tttg, tibial tray implant (lot 108761215), ar-516-7r, femoral implant (lot 108761338), ar-513-bg11, tibial bearing implant (lot 113601405), ar-504-psc9, patella implant (lot 113601430).The revision procedure was completed by implanting another manufacturer's devices.
Additional Manufacturer Narrative
Complaint not confirmed, no evidence was found that may have contributed to the event.During the revision surgery the surgeon chose to also remove this device.The damage observed was most likely caused by the device extraction.

• Brand Name: IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
• Common Device Name: - PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9272306
• Report Number: 1220246-2019-01391
• Device Sequence Number: 13926256
• Product Code: KRR
• UDI-Device Identifier: 00888867035560
• UDI-Public: 00888867035560
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 11/30/2019
• Device Model Number: IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
• Device Catalogue Number: AR-504-PSC9
• Device Lot Number: 113601430
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR