Mpact Acetabular System 01.32.3648HC10ARecalls & reported problems
Medacta International SA · Face-changing 10° PE HC liner Ø36/F · Class 2 · Implant
All models of Mpact Acetabular System (68)
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 07630040731072), received between Sep 27, 2021 and Dec 22, 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
Patient problems
- Joint Dislocation3
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT UNDERWENT PRIMARY RIGHT HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE FEMORAL HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER (MDR: (B)(4). ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE FEMORAL HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND UPSIZED THE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23864303 ↗InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT UNDERWENT THA WITH COMPETITOR PRODUCTS. ON (B)(6) 2025 THE PATIENT UNDERWENT REVISION DUE TO PAIN. THE SURGEON REVISED THE COMPETITOR SHELL TO MEDACTA MPACT 3D MH SHELL AND THE COMPETITOR LINER TO A MEDACTA FACE CHANGING LINER. THE COMPETITOR HEAD WAS REVISED TO A COMPETITOR HEAD. IMMEDIATE POSTOP XRAYS SHOWED DISLOCATION OF THE HEAD FROM THE LINER. THE PATIENT WAS REVISED AGAIN ON THE SAME DAY. THE SURGEON UPSIZED THE MEDACTA LINER AND REVISED THE COMPETITOR HEAD WITH A COMPETITOR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23836935 ↗InjuryDec 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 15905049 ↗InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem
11 DAYS AFTER THE PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 12532781 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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