Mpact Acetabular System 01.32.3644HC10ARecalls & reported problems
Medacta International SA · Face-changing 10° PE HC liner Ø36/E · Class 2 · Implant
All models of Mpact Acetabular System (68)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040731034), received between Jan 21, 2021 and Sep 5, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated7
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Implant Pain4
- Joint Dislocation2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. (MDR 2025-00769) ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND LINER TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 22977014 ↗InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 21642678 ↗InjuryJan 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY DUE TO A DISLOCATION OF THE HEAD OF THE COMPETITOR FROM THE MEDACTA LINER. AT ABOUT 3 WEEKS FROM PRIMARY, THE SURGEON REVISED THE CUP AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A DIRECT ANTERIOR APPROACH WAS UTILIZED IN THE PRIMARY SURGERY.
Patient problems: Implant Pain
MAUDE report 21146977 ↗InjuryOct 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN, DUE TO A DISLOCATION OF THE COMPETITOR HEAD FROM THE MEDACTA LINER, AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED MEDACTA FLAT LINER WITH A MEDACTA FACE CHANGING LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A DIRECT ANTERIOR APPROACH WAS UTILIZED IN THE PRIMARY SURGERY.
Patient problems: Implant Pain
MAUDE report 20359324 ↗InjuryApr 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT WAS CAUSED FROM FALLING. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, SCREWS AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 19039614 ↗InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6)2023. IMMEDIATELY AFTER THE PRIMARY SURGERY, IN POST-OP RECOVERY ON (B)(6)2023, THE PATIENT'S HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6)2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389616 ↗InjuryJan 21, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
4 MONTHS AFTER THE PREVIOUS REVISION SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE BIOLOX HEAD AND SLEEVE, AND FACE CHANGING LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FIRST REVISION SURGERY WAS PERFORMED ALSO DUE TO DISLOCATION (HEAD AND LINER REVISED).
Patient problems: Joint Dislocation
MAUDE report 11207698 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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