Mpact Acetabular System 01.32.2837HCTRecalls & reported problems
Medacta International SA · Flat PE HC liner Ø 28 / B · 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 07630030811531), received between Jan 17, 2018 and Jul 16, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Joint Dislocation3
- Joint Disorder2
- Unspecified Infection2
- Implant Pain1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT 5 YEARS 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE FLAT PE HC LINER TO A FACE CHANGE 10° PE HC LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 22518827 ↗InjuryJan 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION, HEAD FROM THE LINER, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 16173753 ↗InjuryAug 3, 2022Appropriate Device Problem Term/Code Not Available
AT ABOUT 1 MONTH 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 15154907 ↗InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER 2 MONTHS AFTER THE PRIMARY SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation; Pain
MAUDE report 12787117 ↗InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem
3 WEEKS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 12091121 ↗InjuryNov 18, 2019Device Dislodged or Dislocated
THE PATIENT CAME IN, 8 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO DISLOCATION. THE STEM AND HEAD WERE DISLOCATING FROM THE LINER AND CUP. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND THE LINER.
Patient problems: Joint Dislocation
MAUDE report 9334342 ↗InjuryOct 26, 2018Device Dislodged or Dislocated
2 WEEKS AFTER THR (LATERAL APPROACH) AND DURING HYPERFLEXION + ABDUCTION ACTIVITY (SITTING AND TRYING TO DRY THE FEET AFTER A SHOWER), PATIENT FELT SEVERE PAIN: DISLOCATION WAS DIAGNOSED (FEMORAL HEAD DISLOCATED FROM THE MODULAR LINER). CLOSED REDUCTION UNDER ANAESTHESIA WAS SUCCESSFULLY PERFORMED. NO DEVICE WAS EXPLANTED. SURGEON STATEMENT: THE DYNAMIC PELVIS TILT IS PROBLEMATIC WITH THIS PATIENT DUE TO HER SPINE PELVIC RELATIONSHIP. HE IS ALSO CONCERNED ABOUT MINIMAX NECK ANTEVERSION.
Patient problems: Joint Disorder
MAUDE report 8009365 ↗InjuryJan 17, 2018Device Dislodged or Dislocated
REVISION SURGERY DUE TO DISLOCATION. NO TRAUMA REPORTED.
Patient problems: Joint Disorder
MAUDE report 7199212 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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