Mpact Acetabular System 01.32.154DHTRecalls & reported problems
Medacta International SA · Acetabular shell Ø54 Two-holes T · Class 2 · Implant
All models of Mpact Acetabular System (68)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630345798763), received between Feb 11, 2025 and Jan 23, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 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
- Osseointegration Problem2
- Malposition of Device1
Patient problems
- Implant Pain2
- Aseptic loosening1
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Osseointegration Problem
AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE CUP AND IT WAS DETERMINED THAT THERE WAS NO BONE GROWTH ON THE IMPLANT WHICH WAS THE CAUSE. THE SURGEON REVISED THE D 54 SHELL TO A D 62 MULTI-HOLE SHELL, THE 36MM BIOLOX HEAD S TO A 36MM BIOLOX XL. AND THE D 36/F LINER TO A D 36/G LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 24162759 ↗InjuryDec 18, 2025Malposition of Device; Malposition of Device
TWO MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT RETURNED DUE TO PAIN. THE SURGEON DISCOVERED THAT THE ACETABULAR CUP HAD SPUN AND BECOME VERTICAL. A MULTI-HOLE CUP WAS IMPLANTED WITH TWO 25 MM SCREWS, AND THE HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 23837280 ↗InjuryFeb 11, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT TWO MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SHIFTED CUP THAT OCCURRED AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE CUP, SCREW, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 21353075 ↗
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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