Mpact 3D MetalRecalls & reported problems across all models

We found 8 models of Mpact 3D Metal by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2019 and May 29, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Mpact 3D Metal problems

Mpact 3D Metal models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mpact 3D Metal 01.38.052DH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  7 reports
• Mpact 3D Metal 01.38.054DH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  6 reports
• Mpact 3D Metal 01.38.050DH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  4 reports
• Mpact 3D Metal 01.38.058DH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• Mpact 3D Metal 01.38.048DH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• Mpact 3D Metal 01.38.056DH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• Mpact 3D Metal 01.38.054MH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report
• Mpact 3D Metal 01.38.060MH

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report

Recent Mpact 3D Metal adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Osseointegration Problem

  AT ABOUT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING MILD PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA OR INFECTION INDICATED. AFTER AN ORTHOPEDIC SURGEON OBSERVATION, THE CUP LOOSENING HAD INCREASED. THE SURGEON REVISED THE AMISTEM-P COLLARED SIZE 3 TO A QUADRA-P CEMENTED SIZE 2, THE 36MM BIOLOX HEAD S TO AN HEAD L, THE HOODED PE HC LINER D 36/E TO A D 36/F, AND THE MPACT 3D METAL SHELL TWO HOLE D 54MM TO A MULTI HOLE D 60MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25328462 ↗
• InjuryMay 8, 2026Osseointegration Problem

  REVISION SURGERY DUE TO ACETABULAR CUP LOOSENING AFTER ABOUT 2 YEARS AND 10 MONTHS FROM PRIMARY. THE PATIENT STATED THAT PAIN BEGAN AFTER STANDING FROM A SEATED POSITION. THE SURGEON REVISED THE MEDACTA ACETABULAR CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE 36MM BIOLOX HEAD L TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25123191 ↗
• InjuryApr 17, 2026Osseointegration Problem; Positioning Problem

  THE PATIENT HAD PAIN AS A RESULT OF A LOOSE CUP. AT ABOUT 2 YEARS AND 8 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER, AND REVISED THE MEDACTA COCR Ø36MM HEAD TO A MEDACTA 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED BY THE AGENT THAT AN FIBROUS BUILDUP (CAUSED ORIGINIALLY BY A SUBOPTIMAL POSITIONING OF THE SHELL) IN THE JOINT COULD HAVE CONTRIBUTED TO THE IMPLANT LOOSENING, BUT THERE IS NO CONFIRMATION THAT THIS COULD BE THE REASON FOR REVISION AND PATIENT PAIN AND SUCCESSIVE LOOSENING.

  Patient problems: Aseptic loosening

  MAUDE report 24911611 ↗
• InjuryFeb 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD HIP INSTABILITY DUE TO IMPLANT MIGRATION. THE SURGEON OBSERVED THAT THE ACETABULAR COMPONENT DID NOT HAVE ANY BONEY GROWTH AND MIGRATED SUPERIORLY AND MEDIALLY WITH A SLIGHT PROTRUSION. AT ABOUT 1 YEAR AND 6 MONTHS POST OP THE SURGEON REVISED ALL THE ACETABULAR COMPONENTS, HEAD, AND LINER TO A LARGER SIZE FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24454907 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN DUE TO A MISPOSITIONED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE MALPOSITIONED CUP IS UNKNOWN. THE HEAD WAS REVISED TO ADD MORE STABILITY.

  Patient problems: Pain

  MAUDE report 22343744 ↗
• InjuryMar 27, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEON REVISED THE CUP, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21709025 ↗
• InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND UNSTABLE HIP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP, SCREWS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19806143 ↗
• InjuryMay 15, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 2 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD, SLEEVE AND LINER.

  Patient problems: Pain

  MAUDE report 19318551 ↗
• InjuryMar 1, 2024Positioning Problem; Positioning Problem

  REVISION SURGERY DUE TO PAIN AND CUP POSITIONED TOO VERTICAL, AT ABOUT 1 YEAR 5 MONTHS AFTER PRIMARY. CUP, LINER AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18817503 ↗
• InjuryJan 15, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED THE CUP, LINER, HEAD AND STEM AND PLACED AN ANTIBIOTIC SPACER PER THE 2 STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18510521 ↗
• InjuryDec 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. WHILE THE SURGEON WAS PERFORMING A WASHOUT, HE OBSERVED THE CUP WAS LOOSE DUE TO INFECTION. THE SURGEON REVISED THE CUP, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18324593 ↗
• InjuryJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ILIOPSOAS TENDONITIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inflammation

  MAUDE report 17256405 ↗
• InjuryApr 21, 2023Malposition of Device; Malposition of Device

  DURING THE IMPACTION OF THE LINER INTO THE TWO-HOLE CUP, IT WAS NOT POSSIBLE TO PLACE THE ACETABULAR SHELL IN THE CORRECT POSITION. IT WAS PLACED TOO MUCH ON THE PELVIC SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING A MULTI-HOLE CUP AND 4 SCREWS. DELAY TIME 40MIN AND THE TOTAL TIME 170MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783224 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING GROIN PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON BELIEVED THAT A LOOSE ACETABULAR IMPLANT WAS PRESENT. DURING THE REVISION SURGERY (AT ABOUT 2 YEARS AND 5 MONTHS FROM PRIMARY), HOWEVER, THE SURGEON NOTED THAT THE JOINT WAS STABLE AND THE CUP WAS DIFFICULT TO REMOVE. THE SURGEON DID OBSERVE THAT THERE WAS CIRCUMFERENTIAL BONY INGROWTH AS HE REMOVED THE CUP. THE SURGEON REVISED THE MEDACTA CUP, LINER, AND SCREWS WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO COMMENT FROM THE SURGEON ABOUT A POSSIBLE REASON OF PATIENT'S PAIN. THE SURGEON HAS NO REASON/THEORY ABOUT WHAT THE CAUSE OF THE PAIN WAS.

  Patient problems: Pain

  MAUDE report 16435539 ↗
• InjuryAug 18, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 1 MONTH AFTER THE PRIMARY SURGERY AND IT WAS OBSERVED THAT THE ACETABULAR CUP MOVED AND IS IN PROTRUSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15247649 ↗

Other Medacta International SA products

• GMK Sphere Total Knee System209 models · 2,306 reports
• GMK Primary Total Knee System99 models · 876 reports
• Shoulder System63 models · 716 reports
• AMIStem H Femoral Stems20 models · 679 reports
• Mpact Acetabular System68 models · 609 reports
• Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
• Quadra H femoral stems32 models · 354 reports
• MectaLIF Anterior6 models · 4 reports · 6 recalls