MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA FEM IMP PS,CEMENTED SZ 5 LFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBAL TKA FEM IMP PS,CEMENTED SZ 5 LFT
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Discomfort (2330)
Date of Event	10/24/2018
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem 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: IBAL TKA FEM IMP PS,CEMENTED SZ 5 LFT
• 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: 8116992
• Report Number: 1220246-2018-00773
• Device Sequence Number: 13876093
• Product Code: JWH
• UDI-Device Identifier: 00888867109346
• UDI-Public: 00888867109346
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 02/29/2020
• Device Model Number: IBAL TKA FEM IMP PS,CEMENTED SZ 5 LFT
• Device Catalogue Number: AR-516-5L
• Device Lot Number: 1476178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/29/2018
• 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: 62 YR