Bipolar Heads 25060.2858Recalls & reported problems
Medacta International SA · Ø28x58 · Class 2 · Implant
All models of Bipolar Heads (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030843877), received between Nov 28, 2025 and Nov 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2025, PRIMARY SURGERY WITH HIP HEMIARTROPLASTY. THE SALES REPRESENTATIVE WAS IN THE OR AND NO CRITICISM IN THE BIPOLAR ASSEMBLY WAS REPORTED. NO TRAUMATIC EVENTS REPORTED AFTER THE PRIMARY, BUT THE SURGEON SUSPECTS THAT THE PATIENT COULD HAVE DONE INADEQUATE MOVEMENTS. THE PATIENT HAS AVERAGE-LOW ACTIVITY LEVEL. ON (B)(6) 2025, THE COCR HEAD DETACHED FROM THE BIPOLAR HEAD WHILE REMAINING ENGAGED ON THE STEM. THE SURGEON WHO HAD PERFORMED THE INITIAL SURGERY CARRIED OUT A CLOSED REDUCTION AND APPLIED A BRACE. HOWEVER, THE HEAD DISSOCIATED FROM THE BIPOLAR AGAIN ON (B)(6) 2025, MAKING A SECOND INTERVENTION NECESSARY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. THE SURGEON CONVERTED THE CONSTRUCT TO A TOTAL HIP PROSTHESIS, RETAINING ONLY THE STEM IMPLANTED DURING THE PRIMARY.
Patient problems: Joint Dislocation
MAUDE report 23669503 ↗
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.
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