Mpact 3D Metal Acetabular System 01.38.348MHRecalls & reported problems
Medacta International SA · Acetabular shell Ø48 Multi-hole Thin · Class 2 · Implant
Data updated Oct 18, 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 07630971212565), received between Feb 9, 2023 and May 15, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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
- Osseointegration Problem3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bone Fracture(s)2
- Aseptic loosening1
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Osseointegration Problem; Osseointegration Problem
FEW DAYS AFTER PRIMARY SURGERY IT WAS NOTICED DURING A POSTOPERATIVE CHECK THAT THE NATIVE ACETABULUM WAS PERFORATED LEADING TO A MOBILIZATION OF THE CUP. DURING THE REVISION, THE SURGEON NOTICED THAT THE STEM WAS MOBILIZED TOO. PROBABLY DUE TO THE STEM BEING UNDERSIZED. SURGEON REVISED ALL COMPONENTS AND SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Bone Fracture(s)
MAUDE report 22024372 ↗InjuryMay 16, 2024Osseointegration Problem; Osseointegration Problem
THE PATIENT WILL BE REVISED FOR CUP LOOSENING ON THE. INFORMATION WILL BE UPDATED WHEN AVAILABLE AFTER REVISION SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 19328671 ↗InjuryFeb 9, 2023Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available
AT 5 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR MPACT MH 3D METAL MOBILIZATION. COMPETITOR PLATES AND APRICOT USED TO COMPLETE THE SURGERY. SURGEON COMMENT: ALTHOUGH IT WAS NOT CLEAR FROM THE CT, THE MRI SHOWED THAT THE BONES HAD FRACTURED AT THE BASE OF THE ACETABULUM, WHICH MAY HAVE CAUSED THE CUP TO MOVE WITHOUT BONE ADHESION.
Patient problems: Bone Fracture(s); Pain
MAUDE report 16334678 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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