MAUDE Adverse Event Report: UNITED ORTHOPEDIC USTAR II SYSTEM PRESS-FIT CURVED STEM, RHS; HIP STEM

Model Number	PE1115-1413
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon reported that prior to implanting the ustar ii curved stem he noticed that the direction of bend was incorrect.He then implanted the ustar ii straight stem and completed the surgery without incident.No patient harm was reported.Examination of the device against the drawing confirmed that the stem is bent at a wrong angle, 180 degrees from that intended.Root cause investigation found that production does not have poka-yoke for the bending direction and that the testing process for identifying improper bending was inadequate.A recall of ustar ii curved stems is being conducted.Returned devices will be inspected, and the defective items destroyed.New devices will be produced and tested in accordance with the findings of the investigation.
Event or Problem Description
During a hip reconstruction surgery in taiwan, the surgeon found that the hip stem curvature of the selected hip stem was incorrect prior to implanting the device and the surgeon ended up using a straight stem to finish the case.No patient harm was reported.

• Brand Name: USTAR II SYSTEM PRESS-FIT CURVED STEM, RHS
• Common Device Name: HIP STEM
• Manufacturer (Section D): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city, tw 30075 ; TW 30075
• MDR Report Key: 18509141
• Report Number: 3009760038-2024-00001
• Device Sequence Number: 20784061
• Product Code: LPH
• UDI-Device Identifier: 04719872153900
• UDI-Public: (01)04719872153900(17)270323(10)21D512E11
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024
• Report Date (Section F): 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PE1115-1413
• Device Lot Number: 21D512E11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/02/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: USTAR LEFT PROXIMAL FEMORAL COMPONENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/12/2024