Bipolar Heads 25060.2844Recalls & reported problems
Medacta International SA · Ø28x44 · Class 2 · Implant
All models of Bipolar Heads (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030843594), received between May 14, 2018 and Feb 16, 2023 — classified as 4 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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated2
Patient problems
- Unspecified Infection2
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR SHELL FROM THE ACETABULUM. THE CAUSE OF THE DISLOCATION IS UNKNOWN. AT ABOUT 2 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE PATIENT FROM A HEMI TO A TOTAL HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 16385149 ↗InjurySep 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AFTER THE PRIMARY DUE TO DISLOCATION OF THE CERAMIC HEAD FROM THE BIPOLAR HEAD AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445299 ↗InjuryFeb 28, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY AND WASHOUT PERFORMED ONE MONTH AFTER PRIMARY SURGERY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE BIPOLAR HEAD AND THE COCR HEAD HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8377330 ↗InjuryMay 14, 2018Appropriate Device Problem Term/Code Not Available
PATIENT HAD INFECTION 3 WEEKS AFTER PRIMARY: THE SURGEON BELIEVED THAT IT WAS MORE OF A SUPERFICIAL INFECTION, BUT AS A PREVENTATIVE HE CHANGED OUT THE BIPOLAR HEAD AND THE FEMORAL HEAD. HE ALSO TOOK SAMPLES AND AS THE RESULTS CAME BACK (B)(6) FOR (B)(6) , ON (B)(6) 2018 HE PERFORMED ANOTHER WASHOUT AND REMOVED THE HEAD LOT 176024 AND THE BIPOLAR HEAD LOT 171298.
Patient problems: Unspecified Infection
MAUDE report 7510727 ↗
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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