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
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/29/2019
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 the patient underwent a left tka procedure on (b)(6) 2013.During this procedure the following devices were implanted: ar-503-ttte (lot 108761149), ar-503-psle, femoral implant (lot 108761204), ar-503-be09, bearing implant (lot 654422), ar-504-psb8, patella implant (lot 654465).Almost immediately after the surgery the patient began experiencing pain and a clicking/crunching sound in her knee.The patient reported she followed all post-surgery orders and performed all the physical therapy as ordered.During the course of the first year after the tka procedure, the surgeon had to drain fluid from the patient¿s knee three or four times.The patient continued to experience pain and the clicking/crunching sound.On (b)(6) 2014, the original tka surgeon performed a procedure to clean out the scar tissue from the patient¿s joint.The patient¿s issues still persisted.Since the scar tissue removal procedure, the patient had a bone scan that indicated the knee joint had an infection in the joint/bone/tissue or an implant was loose.According to the patient the original tka surgeon was not alarmed or concerned by the bone scan findings and informed her that the knee was fine and the pain and sounds/feelings she was experiencing were normal.The patient continued living with the pain and clicking/crunching sound in her knee and had to take aleve daily to try and tolerate the issues.In 2019, the patient was seen by a different surgeon for a second option, this surgeon advised her that the bone scan findings and tests indicated that she needed a tka revision.Thereafter, on (b)(6) 2019 a left revision tka procedure was performed by the second option surgeon.At the time of revision all original arthrex tka components were explanted and another manufacturer's product was used to complete the revision procedure.Since revision, the patient has been rehabbing and is no longer experiencing the issues previously reported.The patient states that the facility has confirmed the explanted devices are being held and she will request that the facility return the devices to arthrex.Additional information obtained 10/31/19: the following devices were implanted during the (b)(6) 2013 procedure and explanted during the (b)(6) 2019 procedure: ar-503-ttte, tibial tray implant (lot 108761149), ar-503-psle, femoral implant (lot 108761204), ar-503-be09, bearing implant (lot 654422), ar-504-psb8, patella implant (lot 654465).

• Brand Name: IBALANCE PATELLA IMPLANT DOME, 30 X 8 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: 9369117
• Report Number: 1220246-2019-01436
• Device Sequence Number: 16700494
• Product Code: KRR
• UDI-Device Identifier: 00888867035553
• UDI-Public: 00888867035553
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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 PATELLA IMPLANT DOME, 30 X 8 MM
• Device Catalogue Number: AR-504-PSB8
• Device Lot Number: 654465
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other