Bipolar Heads 25060.2851Recalls & reported problems
Medacta International SA · Ø28x51 · Class 2 · Implant
All models of Bipolar Heads (15)
Data updated Oct 18, 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 07630030843730), received between Apr 22, 2021 and Apr 7, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Degraded” (1 report).
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Degraded1
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
Patient problems
- Joint Dislocation2
- Osteolysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY WAS PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO INTRA-PROSTHETIC DISLOCATION. SEVERAL ATTEMPTS OF CLOSED REDUCTION WERE PERFORMED ON THE PATIENT TO TRY TO RESOLVE THE DISLOCATION. THE SURGEON REVISED THE BIPOLAR HEAD, CERAMIC HEAD, AND STEM WHICH APPEARED TO BE LOOSE DUE TO AGGRESSIVE MANEUVERS OF CLOSE REDUCTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 14039889 ↗InjuryJun 10, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED 11 DAYS AFTER THE PRIMARY DUE TO BIPOLAR HEAD LUXATION POSTERIORLY FROM THE ACETABULUM. THE SURGEON SUCCESSFULLY REVISED THE BIPOLAR HEAD, COCR HEAD AND STEM.
Patient problems: Joint Dislocation
MAUDE report 11973431 ↗InjuryApr 22, 2021Degraded
THE PATIENT CAME IN REPORTING PAIN. THE SURGEON DISCOVERED THAT THE PATIENT'S ACETABULUM WAS WORN OUT DUE TO OSTEOLYSIS. 2 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE BIPOLAR HEAD AND IT'S INTERNAL CERAMIC HEAD. NO SIGNS OF DAMAGE FOUND ON THE BIPOLAR HEAD.
Patient problems: Osteolysis
MAUDE report 11705861 ↗
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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