"UNITED" USTAR II Knee System 2115-3410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04719872179443), received between Dec 4, 2024 and Aug 13, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Break

  A complaint case regarding the distal femoral component was received by the French branch on (b)(6) 2026. A 51-year-old male patient underwent TKA surgery using the USTAR II Knee System on (b)(6) 2024. The patient experienced a fall several months earlier and subsequently developed pain. At the follow-up visit on (b)(6) 2026, the X-ray showed intra-articular bone fragments and fracture of the prosthesis hinge component. A revision surgery was performed on (b)(6) 2026.

  Patient problems: Bone Shedding Debris; Limb Pain

  MAUDE report 50232496 ↗
• InjuryApr 29, 2026Break; Fracture; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT TKA SURGERY ON (B)(6) 2024. THE PATIENT BEGAN EXPERIENCING NOISE DURING KNEE MOVEMENT AFTER SURGERY; A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. THE HINGE CONSTRUCTURE FAILURE OF IMPLANTS WAS OBSERVED.

  Patient problems: Hyperextension

  MAUDE report 25038509 ↗
• InjuryApr 29, 2026Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Misassembled During Installation

  A PATIENT UNDERWENT AN IMPLANTATION WITH USTAR II KNEE SYSTEM AND EXPERIENCED A DISSOCIATION OF THE USTAR II DISTAL FEMORAL COMPONENT ON (B)(6) 2020. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 25038504 ↗
• InjuryDec 12, 2024Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2024, A FEMALE PATIENT (M.A.E., 120 LBS) UNDERWENT A SURGERY USING THE USTAR II KNEE SYSTEM. THE PROCEDURE INVOLVED IMPLANTATION OF THE FOLLOWING COMPONENTS: 1. USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT (PN: 2115-3410, LOT: 23J480A) 2. USTAR II KNEE SYSTEM XPE TIBIAL INSERT, S, 12MM (PN: 2315-3211, LOT: 23E194A) THE SURGERY FOLLOWED STANDARD PROTOCOLS AND WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POST-OPERATIVE RECOVERY PROCEEDED AS EXPECTED, AND THE PATIENT WAS DISCHARGED. APPROXIMATELY FOUR MONTHS POST-SURGERY, WHILE AMBULATING WITHOUT ADDITIONAL LOAD, THE PATIENT REPORTED AN AUDIBLE "POP" FOLLOWED BY KNEE INSTABILITY. CLINICAL EXAMINATION AND IMAGING STUDIES REVEALED IMPLANT FRACTURE NECESSITATING REVISION SURGERY ON (B)(6) 2024. IT IS NOTED THAT SURGEON WHO PERFORMED INITIAL SURGERY ON (B)(6) 2024 AND THE SURGERY PERFORMING ON (B)(6) 2024 (DR. (B)(6) MD) CHOSE TO USE THE SAME USTAR II KNEE SYSTEM TO PERFORM REVISION SURGERY. THE REVISION PROCEDURE, PERFORMED ON (B)(6) 2024, INVOLVED: 1 EXPLANTATION OF THE ORIGINAL COMPONENTS (PN: 2115-3410, LOT: 23J480A AND PN: 2315-3211, LOT: 23E194A). 2 IMPLANTATION OF NEW USTAR II KNEE SYSTEM COMPONENTS

  Patient problems: Joint Laxity; Limb Pain

  MAUDE report 20919918 ↗
• InjuryDec 4, 2024Break; Material Separation; Detachment of Device or Device Component; Break; Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2024, A FEMALE PATIENT (M.A.E., 120 LBS) UNDERWENT A SURGERY USING THE USTAR II KNEE SYSTEM. THE PROCEDURE INVOLVED IMPLANTATION OF THE FOLLOWING COMPONENTS: 1. USTAR II KNEE SYSTEM DISTAL FEMORAL COMPONENT, RHS, S, RIGHT (PN: 2115-3410, LOT: 23J480A). 2. USTAR II XPE TIBIAL INSERT, S, 12MM (PN: 2315-3211, LOT: 23E194A). THE SURGERY FOLLOWED STANDARD PROTOCOLS AND WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POST-OPERATIVE RECOVERY PROCEEDED AS EXPECTED, AND THE PATIENT WAS DISCHARGED. APPROXIMATELY FOUR MONTHS POST-SURGERY, WHILE AMBULATING WITHOUT ADDITIONAL LOAD, THE PATIENT REPORTED AN AUDIBLE "POP" FOLLOWED BY KNEE INSTABILITY. CLINICAL EXAMINATION AND IMAGING STUDIES REVEALED IMPLANT FRACTURE NECESSITATING REVISION SURGERY ON (B)(6) 2024. IT IS NOTED THAT SURGEON WHO PERFORMED INITIAL SURGERY ON (B)(6)2024 AND THE SURGERY PERFORMING ON (B)(6)2024 (DR.(B)(6) MD) CHOSE TO USE THE SAME USTAR II KNEE SYSTEM TO PERFORM REVISION SURGERY. THE REVISION PROCEDURE, PERFORMED ON (B)(6) 2024, INVOLVED: 1 EXPLANTATION OF THE ORIGINAL COMPONENTS (PN: 2115-3410, LOT: 23J480A AND PN: 2315-3211, LOT: 23E194A). 2 IMPLANTATION OF NEW USTAR II KNEE SYSTEM COMPONENTS: A) USTAR II

  Patient problems: Joint Laxity; Limb Pain

  MAUDE report 20846835 ↗

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-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-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-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