MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Patient Problem/Medical Problem (2688)

Event Date 10/24/2018

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 cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was originally reported ((b)(4)) by patient's attorney that patient underwent a left total knee replacement procedure on (b)(6) 2015 during which the following arthrex products were implanted: ar-503-ttte, tibial tray, lot 1315453.Ar-516-5l, femoral implant, lot 1476178.Ar-513-be12, tibial bearing, lot 113601433.Ar-504-psb8, patella implant, lot 113601439.Surgeon office records (b)(6) 2016: patient still has some residual stiffness and mild discomfort.Patient reported old pain is gone, pain is better than before surgery.Patient has pain on and off in tibial region and reported knee will swell on occasion.Surgeon office records (b)(6) 2017: patient reported pain in both knees and pain with walking in both knees.Patient reported right knee hurts more than left knee.Patient did not improve with steroid injections.Additional information obtained (b)(6) 2018: patient underwent a revision surgery on (b)(6) 2018 due to painful left total knee arthroplasty, morbid obesity.Operative report (b)(6) 2018: all original components were explanted.Bearing was removed with compression of the tibia.The femur was found to be well fixed.Femur and patella required osteotomes and/or oscillating saw for removal.Tibia was removed with an osteotome.It delaminated from the cement.Cement was well fixed to the tibia.Negative cement mold of the tibia was present and there was no cement on the backside of the tibia.The medical records provided note that the patient is morbidly obese which is a contraindication for this device.

• Brand Name: IBALANCE PATELLA IMPLANT DOME, 30 X 8 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8117015
• MDR Text Key: 128876199
• Report Number: 1220246-2018-00775
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 00888867035553
• UDI-Public: 00888867035553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM
• Device Catalogue Number: AR-504-PSB8
• Device Lot Number: 113601439
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR