MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT AND USTAR II XPE; DISTAL FEMORAL COMPONENT AND XPE TIBIAL INSERT

Model Number	2115-3410 AND 2315-3211
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); Limb Pain (4836)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a female patient (m.A.E., 120 lbs) underwent a surgery using the ustar ii knee system.The procedure involved implantation of the following components: 1.Ustar ii knee system distal femoral component, rhs, s, right (pn: 2115-3410, lot: 23j480a).2.Ustar ii xpe tibial insert, s, 12mm (pn: 2315-3211, lot: 23e194a).The surgery followed standard protocols and was completed without intraoperative complications.Post-operative recovery proceeded as expected, and the patient was discharged.Approximately four months post-surgery, while ambulating without additional load, the patient reported an audible "pop" followed by knee instability.Clinical examination and imaging studies revealed implant fracture necessitating revision surgery on (b)(6) 2024.It is noted that surgeon who performed initial surgery on (b)(6)2024 and the surgery performing on (b)(6)2024 (dr.(b)(6) md) chose to use the same ustar ii knee system to perform revision surgery.The revision procedure, performed on (b)(6) 2024, involved: 1 explantation of the original components (pn: 2115-3410, lot: 23j480a and pn: 2315-3211, lot: 23e194a).2 implantation of new ustar ii knee system components: a) ustar ii knee system distal femoral component, rhs, s, right, rhs, s, right (pn: 2115-3410, lot: 23j482a).B) ustar ii xpe tibial insert, s, 12mm (pn: 2315-3211, lot: 24e813a).The explanted components were requested for return to facilitate a comprehensive root cause analysis by the manufacturer.Investigation aims to determine the exact mechanism of failure and identify any potential manufacturing, design, or surgical factors that may have contributed to the premature implant failure.
Additional Manufacturer Narrative
Investigation in process.

• Brand Name: USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT AND USTAR II XPE
• Common Device Name: DISTAL FEMORAL COMPONENT AND XPE TIBIAL INSERT
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave, science park; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 20846835
• Report Number: 3009760038-2024-00029
• Device Sequence Number: 19765671
• Product Code: KRO
• UDI-Device Identifier: 04719872179443
• UDI-Public: (01)04719872179443(17)280914(10)23J480A
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024
• Report Date (Section F): 12/01/2024

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: 2115-3410 AND 2315-3211
• Device Lot Number: 23J480A AND 23E194A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/26/2024
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 11/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 12/01/2024