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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 10/07/2019

Event Type  Injury  

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 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.

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
• Type of Device: - 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
• MDR Text Key: 165571890
• Report Number: 1220246-2019-01391
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 00888867035560
• UDI-Public: 00888867035560
• Combination Product (y/n): N
• PMA/PMN Number: K160461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR