Mpact Acetabular System 01.32.3244HCTRecalls & reported problems
Medacta International SA · Flat PE HC liner Ø 32 / E · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Medacta Mpact hip liner is a plastic socket insert used in hip replacements. The 24 reports describe hip dislocations where the ball slips out of the liner, liners that did not seat fully during surgery, and infections, often mentioning revision surgery to replace parts. There were no deaths and 24 injuries, and no recalls name 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07630030811913), received between Aug 16, 2017 and Nov 4, 2025 — classified as 24 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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
- Device Dislodged or Dislocated11
- Appropriate Device Problem Term/Code Not Available8
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information2
- Unstable2
- Osseointegration Problem1
- Positioning Failure1
Patient problems
- Unspecified Infection10
- Joint Dislocation9
- Joint Laxity2
- Pain2
- Failure of Implant1
- Inadequate Osseointegration1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 6 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE SYSTEM TO DOUBLE MOBILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23461668 ↗InjuryAug 6, 2025Positioning Failure; Positioning Failure
AFTER THE CUP AND SCREWS WERE INSERTED, THE LINER WAS IMPACTED AS USUAL. HOWEVER, THE LINER WAS NOT FULLY SEATED AND WAS POSITIONED 2 MM ABOVE ITS INTENDED LOCATION. THE SCREW HEADS AND ANY POSSIBLE INTERPOSING MATERIAL WERE CHECKED, AND THE LINER WAS IMPACTED AGAIN, BUT IT STILL DID NOT SEAT COMPLETELY INTO THE CUP. ONE OF THE SCREWS WAS REMOVED AND ANOTHER ATTEMPT WAS MADE TO IMPACT THE LINER, BUT IT COULD NOT BE FIXED SECURELY. DAMAGE WAS OBSERVED ON THE LINER'S TAB, SO A NEW LINER OF THE SAME TYPE BUT DIFFERENT LOT WAS OPENED AND USED. THE SECOND LINER WAS IMPACTED WITHOUT ANY ISSUES. DELAY TIME IS ABOUT 20MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22727963 ↗InjuryJul 16, 2024Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO INSTABILITY AND LAXITY IN THE HIP AND THE CAUSE IS UNKNOWN. ABOUT 8 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (WITH FLAT PE HC LINER Ø36/E) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration; Joint Laxity
MAUDE report 19749803 ↗InjuryMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 4 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER AND THE CUP THAT WAS ORIGINALLY POSITIONED TOO ANTEVERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 17030474 ↗InjuryApr 26, 2022Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 14208038 ↗InjuryMar 17, 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 13802611 ↗InjuryNov 17, 2021Device Dislodged or Dislocated; Appropriate 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 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 12826706 ↗InjurySep 14, 2021Unstable
THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. 5 YEARS AND 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE MPACT FLAT LINER HC 32/E WITH A FLAT PE HC LINER Ø36/E. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 12467904 ↗InjuryMar 30, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER AND ADDED A SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON NOTICED THAT THE PATIENT'S LEG WAS A BIT SHORT IN LENGTH COMPARED TO HIS OTHER LEG, SO HE DECIDED TO UPSIZE THE HEAD DURING THE REVISION TO GIVE THE PATIENT MORE LENGTH IN HIS LEG.
Patient problems: Joint Dislocation
MAUDE report 11587644 ↗InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN 1 MONTH AND 3 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 11580775 ↗InjuryMar 9, 2021Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN. POST-OP X-RAYS INDICATED THAT THE PATIENT SUSTAINED A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON PERFORMED A CLOSED REDUCTION ON THE PATIENT UNDER ANESTHESIA THE DAY AFTER PRIMARY AND NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT SHOULD BE NOTED THAT THE PATIENT WAS MOVED FROM A STRETCHER TO A HOSPITAL BED LOWERING THE PATIENT'S LEG ON THE LEG POSITIONER.
Patient problems: Joint Dislocation
MAUDE report 11444825 ↗InjurySep 29, 2020Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Failure of Implant; Pain
MAUDE report 10600390 ↗InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 2 MONTHS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 10501591 ↗InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY 1 MONTH AFTER PRIMARY.
Patient problems: Unspecified Infection
MAUDE report 10366322 ↗InjuryJun 10, 2020Device Dislodged or Dislocated
IMMEDIATELY FOLLOWING THE PRIMARY HIP SURGERY AND WHILE THE PATIENT WAS IN POST-OP, THE HEAD DISLOCATED FROM THE LINER. THE SURGEON REVISED THE SIZE 4 STEM TO A SIZE 6 STEM AND REVISED THE 32MM BIOLOX HEAD M WITH A 32MM BIOLOX HEAD M THE SAME DAY OF PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 10136933 ↗InjuryOct 2, 2019Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE HEAD 9 MONTHS AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9145160 ↗InjuryApr 3, 2019Device Dislodged or Dislocated
REVISION SURGERY AFTER 1 YEAR AND 2 MONTHS DUE TO PAIN CAUSED BY A DISLOCATION OF THE HEAD FROM THE LINER (AMIS APPROACH WAS USED IN THE PRIMARY SURGERY). THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 8478396 ↗InjuryFeb 28, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY (I&D AND HEAD AND LINER REVISION) DUE TO SIGNS OF INFECTION TWO WEEKS AFTER THE PRIMARY. A WASHOUT WAS THEN PERFORMED FIVE DAYS AFTER REVISION SURGERY DUE TO HIGH LEVEL OF BACTERIA (KLEBSIELLA PNEUMONIAE). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8377332 ↗InjuryJan 23, 2019Device Dislodged or Dislocated
THE PATIENT CAME IN, 2 MONTHS AND 11 DAYS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE A DISLOCATION OF THE HEAD FROM THE LINER. THE DISLOCATION OCCURED WHEN THE PATIENT RAISED HER LEG IN ORDER TO TIE HER SHOE. THE SURGEON REVISED THE CUP, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON USED AN ANTERIOR APPROACH IN THE PRIMARY SURGERY.
Patient problems: Pain
MAUDE report 8270061 ↗InjuryNov 22, 2018Unstable; Device Dislodged or Dislocated
ABOUT 5 MONTHS AFTER PRIMARY THE PATIENT CAME IN DUE TO INSTABILITY: THE PATIENT WAS FOUND TO HAVE A DISLOCATION (HEAD FROM LINER). THE SURGEON SWAPPED THE LINER THROUGH POSTERIOR APPROACH: THE NEW LINER IMPLANTED WAS 01.32.3644HCAT, MPACT HOODED LINER HC 36/E, LOT 172564. THE REVISION WAS SUCCESSFUL. THE PRIMARY SURGERY WAS PERFORMED USING AN ANTERIOR APPROACH (AMIS).
Patient problems: Joint Dislocation
MAUDE report 8098807 ↗InjuryApr 4, 2018Insufficient Device Problem Information
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (PATHOGEN: SERRATIA MARCESCENS) 1 MONTH AFTER PRIMARY. THE SURGEON WASHED OUT THE HIP AND SWAPPED THE HEAD AND LINER.
Patient problems: Unspecified Infection
MAUDE report 7395355 ↗InjuryFeb 28, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION 19 DAYS AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE HIP AND SWAPPED THE HEAD AND LINER.
Patient problems: Unspecified Infection
MAUDE report 7302570 ↗InjuryOct 6, 2017Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS POSITIVE FOR MORGANELLA MORGANII. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 6921438 ↗InjuryAug 16, 2017Insufficient Device Problem Information
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON WASHED OUT THE HIP AND LEFT ALL COMPONENTS IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 6797198 ↗
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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