Bipolar Heads 25060.2850Recalls & reported problems
Medacta International SA · Ø28x50 · Class 2 · Implant
All models of Bipolar Heads (15)
Data updated Oct 18, 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 07630030843716), received between Sep 2, 2019 and Jun 6, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain2
- Implant Pain1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A LINK (COMPETITOR) PROXIMAL FEMORAL REPLACEMENT (STEM AND HEAD) WITH A MEDACTA BIPOLAR SHELL. ON THE (B)(6) 2025, AT ABOUT 1 MONTH FROM THE PRIMARY (ON (B)(6) 2025), THE PATIENT DISLOCATED BIPOLAR HEAD FROM THE NATIVE ACETABULUM. THE SURGEON PERFORMED AN OPEN SURGICAL PROCEDURE TO RELOCATE THE PROSTHESIS AND DURING THE CASE WENT FROM A 49 TO A 50MM BIPOLAR SHELL FOR ADDED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILLED. ON (B)(6) 2025, THE PATIENT HAD PAIN AFTER HIP LUXATION BECAUSE OF THE LACK OF ABDUCTOR TENSION. BECAUSE THE PATIENT HAD A HEMIARTHROPLASTY, THE SURGEON REMOVED ACETABULAR OSTEOPHYTES, OPENED THE ACETABULUM MEDIALLY, AND IMPLANTED A SMALLER BIPOLAR SHELL. HE ALSO CHANGED THE ANTEVERSION OF PROXIMAL FEMORAL REPLACEMENT TO AID WITH HIP STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22156484 ↗InjuryJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY 3 DAYS POST PRIMARY (PATIENT WAS STILL AT THE HOSPITAL) DUE TO DISSOCIATION OF THE INOX HEAD FROM THE BIPOLAR HEAD. IT WAS ALSO REPORTED THAT THE AMISTEM-C STEM WAS FOUND LOOSE. ALL SYSTEM REVISED WITH SAME REFERENCES. NO TRAUMATIC EVENT WAS REPORTED AND NO COMPLICATIONS OCCURRED DURING THE PRIMARY SURGERY; THERE WERE NO MEDACTA EMPLOYEES PRESENT AT EITHER THE PRIMARY OR THE REVISION SURGERY.
Patient problems: Pain
MAUDE report 21167384 ↗InjuryAug 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT 23 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR CUP AND FEMORAL HEAD FROM THE ACETABULUM. THE SURGEON REVISED THE BIPOLAR CUP AND FEMORAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 15300397 ↗InjurySep 2, 2019Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND PUT IN NEW HARDWARE 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8953779 ↗
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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