Bipolar HeadsRecalls & reported problems across all models
Medacta International SA · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 0
We found 15 models of Bipolar Heads by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2017 and Jul 10, 2026 — classified as 40 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bipolar Heads problems
Device problems
- Device Dislodged or Dislocated25
- Appropriate Device Problem Term/Code Not Available10
- Adverse Event Without Identified Device or Use Problem4
- Loose or Intermittent Connection2
- Degraded1
- Device Appears to Trigger Rejection1
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Joint Dislocation19
- Unspecified Infection9
- Pain6
- Implant Pain3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Osteolysis1
Bipolar Heads models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bipolar Heads 25060.2846Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented8 reports
- Bipolar Heads 25060.2845Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented6 reports
- Bipolar Heads 25060.2844Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented4 reports
- Bipolar Heads 25060.2850Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented4 reports
- Bipolar Heads 25060.2847Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented3 reports
- Bipolar Heads 25060.2851Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented3 reports
- Bipolar Heads 25060.2243Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2 reports
- Bipolar Heads 25060.2848Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2 reports
- Bipolar Heads 25060.2849Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2 reports
- Bipolar Heads 25060.2855Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2 reports
- Bipolar Heads 25060.2241Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 report
- Bipolar Heads 25060.2852Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 report
- Bipolar Heads 25060.2853Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 report
- Bipolar Heads 25060.2854Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 report
- Bipolar Heads 25060.2858Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 report
Recent Bipolar Heads adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJul 2, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO DISLOCATION OF BIPOLAR HEAD FROM THE ACETABULUM AFTER 20 DAYS FROM PRIMARY SURGERY. THE SURGEON REVISED THE HEAD WITH A HEAD WITH AN OPTION SLEEVE, AND THE BIPOLAR HEAD WAS CONVERTED TO A ZIMMER DUAL MOBILITY.
Patient problems: Joint Dislocation
MAUDE report 25691655 ↗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 ↗InjuryMar 12, 2026Device Dislodged or Dislocated
AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT EXPERIENCED A HIP DISLOCATION (BIPOLAR FROM THE ACETABULUM) AND, DURING THE ATTEMPT TO PERFORM A CLOSED REDUCTION AT THE HOSPITAL, THE BIPOLAR HEAD DISSOCIATED FROM THE 28 MM FEMORAL HEAD. AN OPEN REDUCTION WAS THEN PERFORMED. THE SURGEON REVISED THE BIOLOX HEAD TO A HEAD OF THE SAME SIZE AND THE BIPOLAR HEAD TO A HEAD OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 24581578 ↗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 ↗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 ↗InjuryNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AFTER TWO MONTHS FROM THE PRIMARY SURGERY, THE BIPOLAR HEAD DISLOCATED FROM THE ACETABULUM. THE SURGEON REVISED THE IMPLANT, CONVERTING THE BIPOLAR SYSTEM TO A TOTAL HIP ARTHROPLASTY.
Patient problems: Joint Dislocation
MAUDE report 23615344 ↗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 ↗InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A COMPETITOR PROXIMAL FEMORAL REPLACEMENT (STEM AND HEAD) WITH A MEDACTA BIPOLAR SHELL. AT ABOUT 1 MONTH FROM THE PRIMARY, 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.
Patient problems: Joint Dislocation
MAUDE report 22011824 ↗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 ↗InjuryMay 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON FOUND ALL COMPONENTS STABLE EVEN WHEN HE REDUCED INTRAOPERATIVELY. HE REVISED THE FEMORAL HEAD TO A XXL AND A NEW 47MM BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 19266711 ↗InjuryMar 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE COCR AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 18985244 ↗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 ↗InjurySep 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 15348737 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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