MAUDE Adverse Event Report: United Orthopedic Corporation USTAR II Knee System; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Catalog Number	2115-3410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Shedding Debris (4557); Limb Pain (4836)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A complaint case regarding the distal femoral component was received by the french branch on (b)(6) 2026.A 51-year-old male patient underwent tka surgery using the ustar ii knee system on (b)(6) 2024.The patient experienced a fall several months earlier and subsequently developed pain.At the follow-up visit on (b)(6) 2026, the x-ray showed intra-articular bone fragments and fracture of the prosthesis hinge component.A revision surgery was performed on (b)(6) 2026.
Additional Manufacturer Narrative
It is confirmed that the production records of the distal femoral component contained no relevant abnormal notes.The final product dimensions, appearance, and inspection values all complied with the specification requirements.As of the reporting date, the complaint product has not yet been obtained.Based on our review of all currently available information, current evidence does not establish a causal relationship between the device and the reported event, and the definitive root cause could not be identified.The final report will be submitted if the complaint product is received and further investigation results are available.

• Brand Name: USTAR II Knee System
• Common Device Name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
• Manufacturer (Section D): United Orthopedic Corporation; no. 57., park ave 2.; science park; hsinchu city, hsinchu city 30075 ; TW 30075
• Manufacturer Contact: ho lois ; no. 57., park ave 2.; science park; hsinchu city, hsinchu city 30075 ; TW 30075
• MDR Report Key: 50232496
• Report Number: 9681642-2026-00031
• Device Sequence Number: 18707530
• Product Code: KRO
• UDI-Device Identifier: 04719872179443
• UDI-Public: 0104719872179443173207041024F670A
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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 Catalogue Number: 2115-3410
• Device Lot Number: 24F670A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 121 LB