Mpact Acetabular System 01.32.152DHRecalls & reported problems
Medacta International SA · Acetabular shell Ø52 Two-holes · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Medacta Mpact hip implant is a cemented or uncemented acetabular cup shell used in total hip replacement. The 36 reports mostly describe pain and infection after surgery, along with hip dislocation, a cup that shifts out of position or sits at the wrong angle, and bone loss around the implant, often leading to revision surgery. No deaths were reported, but 33 injuries were. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07630030810794), received between Jul 13, 2018 and Mar 13, 2026 — classified as 33 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available11
- Adverse Event Without Identified Device or Use Problem6
- Device Appears to Trigger Rejection3
- Loose or Intermittent Connection3
- Malposition of Device3
- Failure to Osseointegrate2
- Migration2
- Positioning Problem2
Patient problems
- Unspecified Infection13
- Pain5
- Inadequate Osseointegration3
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain2
- Joint Disorder2
- Medical device site infection2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Device Appears to Trigger Rejection
AT1 YEAR 5 MONTHS FROM PRIMARY, THEPATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. ALL IMPLANTS WERE REMOVED, AND COMPETITOR`S DEVICES IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 24588561 ↗InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION. THE SURGEON REVISED THE FEMORAL HEAD AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING INFECTION. IMAGING SHOWED AN ANTEVERTED CUP, WITH NO SIGNS OF PERIPROSTHETIC FRACTURE. NO IMPLANTS WERE REMOVED. ON (B)(6) 2025, THE PATIENT HAD A NEW DISLOCATION SUCCESSFULLY TREATED. NO IMPLANTS WERE REMOVED. DURING THE WEEK OF (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION. THE SURGEON THEN IDENTIFIED AN INFECTION, WHICH WAS THE UNIQUE REASON FOR THE REVISION. ALL IMPLANTS WERE REMOVED, AN OSTEOTOMY WAS PERFORMED, AND AN ANTIBIOTIC SPACER WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22539992 ↗InjuryJun 13, 2025Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
AT ABOUT 2 YEARS AND 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22201098 ↗InjuryMay 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT 3 YEARS 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED BONE LOSS AROUND THE CUP AND STEM. THE CUP CAME OUT EASILY, THE STEM HAD ONE SPOT THAT WAS DIFFICULT TO RELEASE, AND THE LINER LOOKED NORMAL. THE SURGEON DECIDED TO REVISE THE CUP, HEAD, LINER AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 22008281 ↗InjuryDec 27, 2024Malposition of Device; Malposition of Device
AT ABOUT 2 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN ANTEVERTED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 21026663 ↗InjurySep 6, 2024Migration; Migration
AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE PATIENT'S CUP BECAME DISLODGED FROM THE ACETABULUM. IT IS UNKNOWN HOW THIS OCCURRED. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20155195 ↗InjuryApr 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED PERMANENT COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 19078273 ↗InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ILIOPSOAS IMPINGEMENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 17773624 ↗InjurySep 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT ABOUT 2 MONTHS AND HALF AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO HIP DISLOCATION CAUSED BY MALPOSITIONING OF THE CUP. THE SURGEON REVISED SUCCESSFULLY CUP COMPONENTS AND HEAD AND IMPLANTED A COMPETITOR'S CUP AND A CONSTRAINED LINER DUE TO PATIENT'S ANATOMY PRESUMABLY INCREASING THE RISK OF DISLOCATION AS WELL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17773089 ↗InjuryJun 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
REVISION SURGERY FOR MPACT DH LOOSENING 1 YEAR AND 11 MONTHS POST-PRIMARY. THE SHELL, LINER AND HEAD HAVE BEEN REVISED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 17181791 ↗InjuryApr 21, 2023Migration; Migration
AT ABOUT 2 YEARS 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED AS PATIENT COMPLAINED OF PSOAS PAIN, MOST LIKELY DUE TO MALPOSITIONING OF THE CUP. THE SURGEON REVISED SUCCESSFULLY CUP, LINER AND HEAD.
Patient problems: Implant Pain
MAUDE report 16784990 ↗InjuryMar 30, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY WAS PERFORMED DUE TO CYST FORMATION AND LOOSENING OF THE FEMORAL COMPONENT, SECONDARY TO INFECTION. THE FIRST STAGE REVISION WAS COMPLETED ALMOST 2 YEARS AND 4 MONTHS AFTER PRIMARY, ALL COMPONENTS WERE REMOVED AND THE CEMENT SPACER WAS INSERTED. STAGE TWO IS TO BE COMPLETED AT A LATER STAGE.
Patient problems: Unspecified Infection
MAUDE report 13947494 ↗InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem
AT 1 MONTH AFTER THE PRIMARY, HIP SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON REVISED ALL THE COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 13058749 ↗InjuryJul 28, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO CUP INSTABILITY AND THE CAUSE OF THE CUP INSTABILITY IS UNKNOWN. 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO CUP LOOSENING DETECTED.
Patient problems: Joint Laxity
MAUDE report 12238522 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem
11 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 12038956 ↗InjuryApr 15, 2021Migration or Expulsion of Device
3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND POST-OP X-RAYS REVEALED THAT THE CUP HAD PERFORATED THE ACETABULAR WALL. THE CAUSE OF THE CUP PERFORATING THE ACETABULAR WALL IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 11670110 ↗InjuryMar 30, 2021Malposition of Device; Malposition of Device
4 YEARS AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE ACETUABULAR COMPONENTS AND THE CERAMIC HEAD. THE REVISION SURGEON STATED THAT THE CUP WAS TOO MUCH ANTEVERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY, ACETABULAR COMPONENTS AND HEAD REVISED.
Patient problems: Insufficient Information
MAUDE report 11587771 ↗InjuryDec 1, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN AN INSTABILITY 2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE POST-OP X-RAYS SHOWED THAT THE CUP WAS ANTEVERTED. THE CAUSE OF THE ANTEVERTED CUP IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR PRODUCTS AND REVISED THE 36MM BIOLOX DELTA HEAD M WITH A 36MM BIOLOX OPTION HEAD. THE SURGEON ALSO ADDED A BIOLOX OPTION SLEEVE L. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF ANY TRAUMATIC EVENT INFLUENCED ON THE PROSTHESIS.
Patient problems: Pain
MAUDE report 10926502 ↗InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN, 15 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D, EXPLANTED ALL IMPLANTS, AND REPLACED THEM WITH NEW IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 10726584 ↗MalfunctionOct 1, 2020Device Dislodged or Dislocated
REVISION SURGERY PERFORMED, 1 DAY AFTER PRIMARY SURGERY, DUE TO DISSOCIATION OF THE LINER FROM THE CUP. RIGHT SIDE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10613014 ↗InjuryOct 1, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED, 1 MONTH AFTER PRIMARY SURGERY, DUE TO INFECTION. RIGHT SIDE.
Patient problems: Unspecified Infection
MAUDE report 10612281 ↗InjuryOct 1, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED DUE TO CUP LOOSENING 4 MONTHS AFTER THE PRIMARY SURGERY. LEFT SIDE.
Patient problems: Inadequate Osseointegration
MAUDE report 10611619 ↗InjurySep 15, 2020Gradient Increase
THE PATIENT HAD A SURGERY IN (B)(6) 2020 DUE TO FEMUR FRACTURE, FIXED WITHOUT USING MEDACTA IMPLANTS. ON (B)(6) 2020 THE PATIENT WAS REVISED TO CONVERT THE FRACTURE FIXATION IN A THA, MEDACTA IMPLANTS WERE USED. ON (B)(6) 2020 THE PATIENT HAS BEEN REVISED DUE TO INFECTION. ALL DEVICES REVISED.
Patient problems: Unspecified Infection
MAUDE report 10535329 ↗InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN 20 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA STEM AND HEAD WITH A MEDACTA STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 10331243 ↗InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 10301338 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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