U2 Femoral component, CR, porous coated 2103-1140Recalls & reported problems
United Orthopedic Corp. · U2 Femoral component, CR, porous coated, #4, left · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04712602345392), received between Apr 29, 2026 and Apr 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Flaked” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Flaked2
- Detachment of Device or Device Component1
- Loss of Osseointegration1
- Loss of or Failure to Bond1
- Material Separation1
- Naturally Worn1
Patient problems
- Limb Pain1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Flaked; Detachment of Device or Device Component; Naturally Worn
THE PATIENT REPORTED PERSISTENT PAIN AFTER HAVING A TKA SURGERY USING THE U2 TOTAL KNEE SYSTEM, AND X-RAY IMAGING REVEALED FEMORAL COMPONENT LOOSENING AND METAL BEADS SHEDDING AT ONE YEAR POST-SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 25038878 ↗InjuryApr 29, 2026Loss of or Failure to Bond; Flaked; Material Separation; Loss of Osseointegration
THE MANUFACTURER WAS NOTIFIED ON SEPTEMBER 30, 2025 THAT A PATIENT REPORTED PERSISTENT PAIN AFTER HAVING A TKA SURGERY USING THE U2 TOTAL KNEE SYSTEM, AND X-RAY IMAGING REVEALED FEMORAL COMPONENT LOOSENING AND METAL BEADS SHEDDING AT 1.5 YEARS POSTOPERATIVELY.
Patient problems: Limb Pain
MAUDE report 25038515 ↗
Other Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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