"UNITED" USTAR II Hip System 1115-1413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04719872153900), received between Jan 12, 2024 and Feb 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (2 reports).

3 FDA recall records name this device's identifier, 3 still open.

2 other recalls cover devices cleared under the same FDA submission (K190100); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 3, 2024Class IIOpen, Classified

   Their is a potential that the implant curved stem may be oriented incorrectly.

   Z-1217-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jan 3, 2024Class IIOpen, Classified

   Their is a potential that the implant curved stem may be oriented incorrectly.

   Z-1216-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jan 3, 2024Class IIOpen, Classified

   Their is a potential that the implant curved stem may be oriented incorrectly.

   Z-1215-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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.

  Patient problems: Joint Dislocation

  MAUDE report 18665422 ↗
• InjuryJan 12, 2024Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509141 ↗
• MalfunctionJan 12, 2024Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190100. One submission often covers many models, so check the product and lot details in each record.

• Z-2884-2026 · May 20, 2026 · Open, Classified
  Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Sof
• Z-0110-2022 · Aug 27, 2021 · Terminated
  United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025