Mpact Acetabular System 01.32.152MHRecalls & reported problems
Medacta International SA · Acetabular shell Ø52 Multi-hole · Class 2 · Implant
All models of Mpact Acetabular System (68)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030810800), received between May 16, 2018 and Nov 5, 2025 — classified as 8 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
- Appropriate Device Problem Term/Code Not Available2
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Osseointegrate1
- Loose or Intermittent Connection1
- Malposition of Device1
Patient problems
- Unspecified Infection3
- Inadequate Osseointegration2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Aseptic loosening1
- Joint Disorder1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2025Osseointegration Problem; Osseointegration Problem
AT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THE PATIENT HAD ASEPTIC LOOSENING OF THE CUP. THE REVISION WAS COMPLETED USING COMPETITOR CUP, AUGMENTS, AND MODULAR DUAL MOBILITY CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 23477175 ↗InjuryMay 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
AT ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD AND LINER.
Patient problems: Inadequate Osseointegration
MAUDE report 16893410 ↗InjuryApr 26, 2023Osseointegration Problem; Osseointegration Problem
REVISION SURGERY AT 25 DAYS FROM PRIMARY SURGERY DUE TO CUP LOOSENING. ACETABULAR COMPONENTS WERE REVISED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 16813625 ↗InjuryFeb 23, 2022Appropriate Device Problem Term/Code Not Available
THE PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, AT 7 MONTHS FROM THE PRECEDENT SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 13584648 ↗InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED 2 YEARS AND 8 MONTHS DUE TO INFECTION. ALL IMPLANTS REMOVED AND SPACER IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 13548449 ↗InjuryMay 20, 2021Malposition of Device; Malposition of Device
PRIMARY PERFORMED IN (B)(6) 2021. POST-OP X-RAYS REVEALED A MALPOSITIONED CUP. IN (B)(6) 2021 THE SURGEON SUCCESSFULLY REVISED THE CUP, LINER, AND HEAD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11854201 ↗InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem
WASHOUT PERFORMED AFTER 2 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND DID NOT EXPLANT ANY IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9376095 ↗InjuryMay 16, 2018Loose or Intermittent Connection
ABOUT 10 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A CUP LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY IMPLANTING A LARGER CUP.
Patient problems: Joint Disorder
MAUDE report 7518547 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page