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	Malfunction
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.
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.

• 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
• Manufacturer (Section G): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city, twn 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57, park ave. 2; science park; hsinchu city, twn 30075 ; TW 30075
• MDR Report Key: 18509075
• Report Number: 9681642-2024-00001
• Device Sequence Number: 20786282
• Product Code: LPH
• UDI-Device Identifier: 04719872153900
• UDI-Public: (01)04719872153900(17)270323(10)21D512E11
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection,Recall
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PENDING
• 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