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

Model Number PE1115-1413

Device Problems Nonstandard Device (1420); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 333107870
• Report Number: 9681642-2024-00001
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04719872153900
• UDI-Public: (01)04719872153900(17)270323(10)21D512E11
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K190100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: PENDING
• Patient Sequence Number: 1
• Treatment: USTAR LEFT PROXIMAL FEMORAL COMPONENT
• Patient Outcome(s): Required Intervention