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

Model Number	2315-3213, 2115-1330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Receiving the awareness of this case from importer, investigation into the cause of the adverse event is in progress.
Additional Manufacturer Narrative
According to the investigation, it is confirmed from the product manufacturing inspection records that the dimensions of the abnormal device met the manufacturing tolerance.From the observation of the returned device, there is no evidence of assembly between the screw taper and the internal taper of the adapter, moreover, significant pressure marks are present on the end face of taper of the screw.Based on the comprehensive analysis, it is inferred that the root cause of this case is misalignment during the assembly of the adapter and screw, ultimately leading to implant dislocation.
Event or Problem 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.

• Brand Name: USTAR II KNEE SYSTEM
• Common Device Name: KNEE REPLACEMENT
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave. 2; 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: 18834187
• Report Number: 9681642-2024-00002
• Device Sequence Number: 12569407
• Product Code: KRO
• UDI-Device Identifier: 04719872179481
• UDI-Public: (01)04719872179481(17)280706(10)23G030A,(01)04711605580328(17)280914(10)23J382B
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/05/2024

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: 2315-3213, 2115-1330
• Device Lot Number: 23J382B, 23G030A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: USTAR FEMORAL COMPONENT, #3, LEFT.; XPE TIBIAL INSERT, RS, S, 17 MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female