United Hip System, U2 Bipolar Implant 1503-3145Recalls & reported problems
United Orthopedic Corp. · U2 Bipolar Implant, 28mm I.D., 45mm O.D. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04712771493979), received between Apr 29, 2026 and Apr 30, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated3
- Device Slipped3
Patient problems
- Joint Dislocation3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Device Slipped; Detachment of Device or Device Component; Device Dislodged or Dislocated
A PATIENT WHO UNDERWENT AN INITIAL SURGERY WITH U2 BIPOLAR IMPLANT ON (B)(6) 2017. A REVISION SURGERY WAS CONDUCTED WITH U2 BIPOLAR IMPLANT ON (B)(6) 2017 DUE TO THE FEMORAL HEAD DISASSOCIATED FROM THE CAP.
Patient problems: Joint Dislocation
MAUDE report 25038875 ↗MalfunctionApr 29, 2026Device Slipped; Detachment of Device or Device Component; Device Dislodged or Dislocated
A PATIENT UNDERWENT A BIPOLAR HIP IMPLANTATION SURGERY ON (B)(6) 2017. THE PATIENT EXPERIENCED DISCOMFORT WHILE BENDING DOWN TO SIT, AND X-RAYS REVEALED A DISSOCIATION BETWEEN THE ACETABULAR CUP AND THE FEMORAL HEAD. A REVISION SURGERY WAS PERFORMED ON THE SAME DAY (B)(6) 2017 TO REPLACE THE IMPLANTS WITH A NEW U2 BIPOLAR IMPLANT AND FEMORAL HEAD.
Patient problems: Joint Dislocation
MAUDE report 25038507 ↗InjuryApr 29, 2026Device Slipped; Detachment of Device or Device Component; Device Dislodged or Dislocated
A PATIENT WHO UNDERWENT AN INITIAL SURGERY WITH U2 BIPOLAR IMPLANT (45MM) ON (B)(6) 2016; SUBSEQUENTLY, A REVISION SURGERY WAS CONDUCTED WITH U2 BIPOLAR IMPLANT (46MM) ON (B)(6) 2017 DUE TO THE FEMORAL HEAD DISASSOCIATED FROM THE CAP WHILE THE PATIENT WAS SITTING IN A SWIVEL CHAIR. HOWEVER, THE DISASSOCIATION OCCURRED AGAIN DURING THE PATIENT WALKING, A RE-REVISION SURGERY WAS CONDUCTED WITH U2 BIPOLAR IMPLANT (45MM) ON (B)(6) 2017.
Patient problems: Joint Dislocation
MAUDE report 25038505 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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