Mpact Acetabular System 01.32.3644HC4Recalls & reported problems
Medacta International SA · Offset 4mm 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
- 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 07630040731058), received between Jul 13, 2021 and May 20, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Joint Dislocation4
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Device Dislodged or Dislocated
THIS WAS THE SECOND REVISION FOR PATIENT. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2024. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2025; THE STEM WAS REVISED, BUT THE REASON IS UNKNOWN. NO OTHER INFO IS AVAILABLE REGARDING THIS REVISION SURGERY. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISLOCATION OF THE HEAD FROM THE LINER. ALL COMPONENTS REVISED WITH DOUBLE MOBILITY COMPETITOR`S COMPONENT. THE REASON FOR REVISION OF THE FEMORAL STEM IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 25230409 ↗InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM, HEAD AND LINER WITH ANOTHER MEDACTA STEM, HEAD AND LINER, AND COMPLAINT (B)(4) WAS FILED. MDR 3005180920-2024-00190 AND 3005180920-2024-00190 FU1. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) FILLED. MDR 3005180920-2025-00204. 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 COMPETITOR HEAD AND MEDACTA LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CUP WAS REVISED JUST BECAUSE THE SURGEON WANTED GIVE IT DIFFERENT POSITIONING/INCLINATION/VERSION THIS TIME.
Patient problems: Joint Dislocation; Pain
MAUDE report 22539699 ↗InjuryMay 24, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. ABOUT 2 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 14485253 ↗InjuryJul 13, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
2 MONTHS AFTER THE PRIMARY SURGERY 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 CUP, HEAD AND LINER.
Patient problems: Joint Dislocation
MAUDE report 12157570 ↗
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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