MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2015
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 reported by the patient's legal representative that the patient had undergone a left knee menisectomy and chondroplasty on (b)(6) 2015.Thereafter, on (b)(6) 2015 the patient had a hemi-arthroplasty on her left knee.The records provided list that the following arthrex products were implanted during the (b)(6) 2015 procedure: ar-501-ttlb ibalance uni-tibial tray (lot 108761228), ar-501-uflc ibalance uni-femoral implant (lot 1470559) and ar-501-tbb0 ibalance uka tibial bearing (lot 77941142).On (b)(6) 2015 the patient underwent another surgery converting the uni-knee to a total knee replacement.According to the medical records the pre-op diagnosis, and x-ray findings prior to the (b)(6) 2015 procedure note a loose femoral component.However, the operative report notes that the tibial baseplate was loose, not the femoral component.During the procedure the hemi-arthroplasty implants were removed and the following left tka ibalance system components were implanted: ar-503-tttd tibial baseplate (lot 1297044), ar-517-4l femoral implant (lot 1438430), ar-503-a313 tibial bearing implant (13mm) (lot 113601414) and ar-504-psa8 patella implant (lot 113601322).Another manufacturer's bone cement was used with the arthrex implants.The medical records provided note that the patient¿s bmi was 38+ which is a contraindication for both the uni and tka devices.

• Brand Name: IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
• 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: 8086820
• Report Number: 1220246-2018-00762
• Device Sequence Number: 11094530
• Product Code: KRR
• UDI-Device Identifier: 00888867034266
• UDI-Public: 00888867034266
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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: 01/31/2020
• Device Model Number: IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
• Device Catalogue Number: AR-501-UFLC
• Device Lot Number: 1470559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/19/2018
• 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: 44 YR
• Patient Weight: 93