MAUDE Adverse Event Report: UNITED ORTHOPEDIC USTAR II KNEE SYSTEM; KNEE REPLACEMENT

Model Number 2315-3213, 2115-1330

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 01/08/2024

Event Type  Injury  

Event Description

The patient reported that they got out of a chair and experienced pain.They indicated no fall or trauma.Previous ustar ii patient presented with pain and instability.X-ray imaging revealed dislocation of the femoral component and tibial insert yoke and a revision was scheduled.During surgery, surgeon noted the insert screw connecting the femoral component insert and yoke had bent.Original surgery was on (b)(6) 2023 and revision was conducted on (b)(6) 2024.Revision surgery was successfully completed.

Manufacturer Narrative

Receiving the awareness of this case from importer, investigation into the cause of the adverse event is in progress.

• Brand Name: USTAR II KNEE SYSTEM
• Type of Device: KNEE REPLACEMENT
• Manufacturer (Section D): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• Manufacturer (Section G): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city,, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57, park ave. 2; science park; hsinchu city,, 30075 ; TW 30075
• MDR Report Key: 18834187
• MDR Text Key: 336850776
• Report Number: 9681642-2024-00002
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04711605580328
• UDI-Public: (01)04711605580328(17)280914(10)23J382B,(01)04719872179481(17)280706(10)23G030A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2315-3213, 2115-1330
• Device Lot Number: 23J382B, 23G030A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: USTAR FEMORAL COMPONENT, #3, LEFT.; XPE TIBIAL INSERT, RS, S, 17 MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female