"UNITED" USTAR II Knee System 2115-1330Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04719872179481), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

5 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 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 18834187 ↗

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-1215-2024 · Jan 3, 2024 · Open, Classified
  USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE1
• Z-1217-2024 · Jan 3, 2024 · Open, Classified
  USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE2515111
• Z-1216-2024 · Jan 3, 2024 · Open, Classified
  USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111-
• 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