Mpact Acetabular System 01.32.150MHRecalls & reported problems
Medacta International SA · Acetabular shell Ø50 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030810770), received between Jul 21, 2017 and Nov 27, 2024 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Osseointegrate1
- Misassembled1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration2
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
AT ABOUT 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 20797662 ↗InjuryAug 23, 2022Osseointegration Problem; Osseointegration Problem
AT ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE CUP HAS MOBILIZED. THE CAUSE OF THIS IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD, LINER AND SCREWS.
Patient problems: Inadequate Osseointegration
MAUDE report 15273675 ↗InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem
ABOUT 10 DAYS AFTER PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT FOR AN INFECTION CASE. CUP, LINER AND BALL HEAD WERE SWAPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8069019 ↗MalfunctionJul 21, 2017Misassembled; Misassembled
DURING SURGERY THE CUP IMPACTOR WOULD NOT DISENGAGE FROM THE CUP. THE SURGEON REMOVED THE IMPACTOR AND CUP. AFTER 10 MINUTES, THE SURGEON WAS ABLE TO DISENGAGE THE CUP FROM THE IMPACTOR. THE SURGEON MANUALLY IMPACTED THE CUP WITH A BALL IMPACTOR. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 6731724 ↗
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 13, 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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