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

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 11/11/2019

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.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 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
• 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: 9473632
• MDR Text Key: 176412278
• Report Number: 1220246-2019-01494
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 00888867034273
• UDI-Public: 00888867034273
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• 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