MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT &XPE TIBIAL INSERT; 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
Additional Manufacturer Narrative
The investigation of this event is in process now.If information is obtained, a follow-up report will be filed as appropriate.
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 knee system 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, (pn: 2115-3410, lot: 23j482a).B) ustar ii knee system 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.
Event or Problem Description
On (b)(6) 2024, a female patient ((b)(6), 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 knee system 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, (pn: 2115-3410, lot: 23j482a).B) ustar ii knee system 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
Based on the returned product, a clear tensile fracture patterns were identified on the adaptor.Additionally, a compressed indentation was observed on the anterior platform of the tibial insert.The distal femoral implant and the tibial insert showed an overall hyperextension condition.There is no non-conformities during the production process.The design of this product's range of motion complies with the requirements of human knee joint movement.The product has also passed hyperextension fatigue tests and astm stp 1301-97 test verification.In summary, it is speculated that the patient in this case frequently experienced anterior tilting of the distal femoral implant due to their knee joint motion patterns.This likely caused hyperextension of the distal femoral implant, ultimately resulting in the tensile fracture of the adaptor under excessive stress.

• Brand Name: USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT &XPE TIBIAL INSERT
• 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
• Manufacturer (Section G): UNITED ORTHOPEDIC CORPORATION; 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: 20919918
• Report Number: 9681642-2024-00034
• Device Sequence Number: 12029173
• 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
• PMA/510(K) Number: K190100
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG