Bipolar Heads 25060.2846Recalls & reported problems
Medacta International SA · Ø28x46 · Class 2 · Implant
All models of Bipolar Heads (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030843631), received between Jul 20, 2018 and Jul 10, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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
- Device Dislodged or Dislocated6
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Patient-Device Incompatibility1
Patient problems
- Joint Dislocation5
- Unspecified Infection2
- Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO JOINT LUXATION BETWEEN BIPOLAR HEAD AND ACETABULUM AFTER ABOUT 2 MONTHS FROM PRIMARY. THE SURGEON REVISED THE HEMI HIP TO A TOTAL HIP.
Patient problems: Joint Dislocation
MAUDE report 25778122 ↗InjuryMay 25, 2026Device Dislodged or Dislocated
AT ABOUT 1 MONTHS FROM THE PRIMARY,THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE BI-POLAR HEAD FROM THE FEMORAL HEAD FOLLOWING A FALL. THE SURGEON REVISED THE BI-POLAR HEAD WITH ANOTHER ONE OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 25268618 ↗InjuryFeb 16, 2026Device Dislodged or Dislocated
THE PATIENT HAD PAIN FROM CHRONIC DISLOCATIONS (BIPOLAR HEAD FROM ACETABULUM BONE) POSTERIORLY AND THE CAUSE IS UNKNOWN. THE DISLOCATIONS WERE TREATED WITH CLOSED REDUCTION. FINALLY, THE SURGEON REVISED THE HIP FROM A HEMI TO A FULL HIP REPLACEMENT AFTER 6 YEARS AND 2 MONTHS FROM THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 24343896 ↗InjuryOct 23, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN, 2 TWO MONTHS AFTER THE PRIMARY SURGERY, DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON REVISED THE BIPOLAR HEAD SIZE 28X46 WITH A BIPOLAR HEAD SIZE 28X46 AND THE 28MM COCR HEAD M WITH A 28MM COCR HEAD L. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 10727243 ↗InjuryJul 28, 2020Device Dislodged or Dislocated
REVISION SURGERY PERFORMED DUE TO DISLOCATION OF THE BIPOLAR HEAD FROM ACETABULAR BONE. BALL HEAD, HEAD AND STEM WERE REVISED 1 MONTH AFTER PRIMARY. THE PATIENT FELL BUT IT IS NOT KNOWN IF THE PATIENT FELL AND LUXATED OR VICE-VERSA.
Patient problems: Joint Dislocation
MAUDE report 10331240 ↗InjuryJun 17, 2020Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISASSOCIATION OF THE BIPOLAR HEAD FROM THE BIOLOX HEAD THAT WAS CAUSED WHEN THE PATIENT WAS GETTING OUT OF BED. THE SURGEON CONVERTED THE PATIENT FROM A BIPOLAR HIP TO A TOTAL HIP 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 10161542 ↗InjuryJan 16, 2019Patient-Device Incompatibility
ABOUT 1 MONTH AFTER PRIMARY FOR AN INFECTION CASE THE SURGEON SURGEON WASHED OUT THE HIP AND REVISED THE BIPOLAR HEAD AND COCR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8252592 ↗InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER PRIMARY. THE PATHOGEN CONFIRMED AS ENTEROCOCCUS FAECALIS. THE SURGEON WASHED OUT THE HIP AND REVISED THE BIPOLAR HEAD AND COCR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 7706393 ↗
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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