Bipolar Heads 25060.2847Recalls & reported problems
Medacta International SA · Ø28x47 · Class 2 · Implant
All models of Bipolar Heads (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030843655), received between Apr 20, 2022 and Jul 2, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Patient Device Interaction Problem1
Patient problems
- Joint Dislocation2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO DISLOCATION OF BIPOLAR HEAD FROM THE ACETABULUM AFTER 20 DAYS FROM PRIMARY SURGERY. THE SURGEON REVISED THE HEAD WITH A HEAD WITH AN OPTION SLEEVE, AND THE BIPOLAR HEAD WAS CONVERTED TO A ZIMMER DUAL MOBILITY.
Patient problems: Joint Dislocation
MAUDE report 25691655 ↗InjuryMay 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON FOUND ALL COMPONENTS STABLE EVEN WHEN HE REDUCED INTRAOPERATIVELY. HE REVISED THE FEMORAL HEAD TO A XXL AND A NEW 47MM BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 19266711 ↗InjuryApr 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
LUXATION OF THE BIPOLAR HEAD FROM THE METALLIC HEAD (INTRA-PROSTHETIC DISLOCATION). THE SURGEON REVISED ALL COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 14157400 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page