MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL; - PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/11/2019
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.It was reported the risk manager will not release the device.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
The patient had original surgery for a uni knee replacement on (b)(6) 2018.She reported pain and instability; xrays showed that the poly had worn down.Arthrex parts ar-521-tba8, ar-501-ufld and ar-501-ttla were removed.A total knee revision was done on (b)(6) 2019 with a competitor's device.Patient female, 60s.

• Brand Name: IBAL UKA FEM CEMENTED SIZ 4,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: 9473632
• Report Number: 1220246-2019-01494
• Device Sequence Number: 10815232
• Product Code: KRR
• UDI-Device Identifier: 00888867034273
• UDI-Public: 00888867034273
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL
• Device Catalogue Number: AR-501-UFLD
• Device Lot Number: 10195016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/16/2019
• 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