Mpact Acetabular SystemRecalls & reported problems across all models
Medacta International SA · 68 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 609
- Deaths reported
- 0
- Injuries reported
- 577
- Recalls
- 0
We found 68 models of Mpact Acetabular System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 609 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 1, 2026 — classified as 577 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (137 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
Reports received per month, all models
Most reported Mpact Acetabular System problems
Device problems
- Appropriate Device Problem Term/Code Not Available179
- Device Dislodged or Dislocated137
- Adverse Event Without Identified Device or Use Problem99
- Device Appears to Trigger Rejection66
- Malposition of Device23
- Osseointegration Problem23
- Loose or Intermittent Connection18
- Unstable16
Patient problems
- Unspecified Infection214
- Joint Dislocation96
- Pain71
- Medical device site infection37
- Inadequate Osseointegration29
- Joint Disorder26
- No Known Impact Or Consequence To Patient26
- Implant Pain24
Mpact Acetabular System models
68 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mpact Acetabular System 01.32.3644HCTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented93 reports
- Mpact Acetabular System 01.32.3648HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented61 reports
- Mpact Acetabular System 01.32.152DHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented36 reports
- Mpact Acetabular System 01.32.3241HCTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented36 reports
- Mpact Acetabular System 01.32.3239HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented24 reports
- Mpact Acetabular System 01.32.3244HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented24 reports
- Mpact Acetabular System 01.32.150DHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented23 reports
- Mpact Acetabular System 01.32.154DHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented23 reports
- Mpact Acetabular System 01.32.156DHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented22 reports
- Mpact Acetabular System 01.32.3652HCTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented21 reports
- Mpact Acetabular System 01.32.158DHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented18 reports
- Mpact Acetabular System 01.32.4048HCTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented16 reports
- Mpact Acetabular System 01.32.4052HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented16 reports
- Mpact Acetabular System 01.32.148DHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented15 reports
- Mpact Acetabular System 01.32.156MHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented10 reports
- Mpact Acetabular System 01.32.3644HCATProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- Mpact Acetabular System 01.32.152MHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented8 reports
- Mpact Acetabular System 01.32.2837HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented8 reports
- Mpact Acetabular System 01.32.3241HCATProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented8 reports
- Mpact Acetabular System 01.32.3248HCTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented8 reports
- Mpact Acetabular System 01.32.146DHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented7 reports
- Mpact Acetabular System 01.32.6535Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented7 reports
- Mpact Acetabular System 01.32.3644HC10AProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented7 reports
- Mpact Acetabular System 01.32.158MHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented6 reports
- Mpact Acetabular System 01.32.6540Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented6 reports
- Mpact Acetabular System 01.32.150SHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Mpact Acetabular System 01.32.150MHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- Mpact Acetabular System 01.32.152SHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- Mpact Acetabular System 01.32.3648HCATProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- Mpact Acetabular System 01.32.6525Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- Mpact Acetabular System 01.32.6530Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- Mpact Acetabular System 01.32.3644HC4Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- Mpact Acetabular System 01.32.3648HC10AProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4 reports
- Mpact Acetabular System 01.32.154MHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Mpact Acetabular System 01.32.154SHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Mpact Acetabular System 01.32.162DHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Mpact Acetabular System 01.32.3239HCATProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Mpact Acetabular System 01.32.6520Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Mpact Acetabular System 01.32.4048HC4Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Mpact Acetabular System 01.32.150DHTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Mpact Acetabular System 01.32.154DHTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented3 reports
- Mpact Acetabular System 01.32.146MHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Mpact Acetabular System 01.32.148MHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.148SHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.160DHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Mpact Acetabular System 01.32.160SHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.162MHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Mpact Acetabular System 01.32.3652HCATProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Mpact Acetabular System 01.32.3239HC4Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.3241HC10AProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.3244HC4Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.3641HC4Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.4052HC10AProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Mpact Acetabular System 01.32.050DHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Mpact Acetabular System 01.32.146SHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Mpact Acetabular System 01.32.156SHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.158SHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Mpact Acetabular System 01.32.166MHProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Mpact Acetabular System 01.32.2839HCATProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Mpact Acetabular System 01.32.2839HCTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.3252HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Mpact Acetabular System 01.32.6515Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.3239HC10AProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.3652HC10AProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.3652HC4Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.144MHTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.146DHTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Mpact Acetabular System 01.32.150MHTProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
Recent Mpact Acetabular System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Naturally Worn
Patient problems: Insufficient Information
MAUDE report 50543234 ↗InjuryAug 27, 2026Device Dislodged or Dislocated
Revision surgery due to joint luxation after about 2 months from primary. The surgeon revised the proximal body, Biolox head and liner along with a DM converter. The surgery was completed successfully.
Patient problems: Joint Dislocation
MAUDE report 50474971 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
The initial canal finder and subsequent broaches exited through the posterior femoral cortex. No bone fracture was reported. The femur was subsequently re-broached and prophylactic cables were applied to reduce the risk of postoperative fracture. At the end of the primary procedure, the hip was considered stable by the surgeon. However, a postoperative dislocation of the femoral head from the cup/liner construct occurred in the recovery area on the same day. The patient subsequently underwent revision surgery due to pain associated with the dislocation. During revision, the D 40/F Flat PE HC liner was replaced with a D 40/F 10° face-changing PE HC liner. The revision procedure was completed successfully.
Patient problems: Joint Dislocation
MAUDE report 50474961 ↗InjuryAug 27, 2026Device Appears to Trigger Rejection
The patient came in due to signs of infection and the pathogen is unknown. About 4 months after the primary surgery, the surgeon performed a washout, I&D, and revised the 36mm Biolox Head M and D 36/E Flat PE HC liner to a same size head and liner. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50474953 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
At about 2 months from the primary,the patient came in due to signs of infection. The surgeon performed a washout and removed theliner and thecompetitor head. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50114121 ↗InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN PRESENTING PAIN DUE TO CUP - ILIOPSOAS IMPINGEMENT AND THE CAUSE IS UNKNOWN. IT HAS BEEN REPORTED THAT PROBABLY THE CUP WAS NOT MEDIALIZED ENOUGH AND HAS BEEN MALPOSITIONED, BUT THERE IS NO CONFIRMATION OF THIS INFORMATION. ABOUT 4 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR IMPLANTS AND REVISED THE HEAD WITH AN L SIZE AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Impingement
MAUDE report 25763493 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY SURGERY WITH COMPETITOR IMPLANTS. ON (B)(6), 2025, THE PATIENT WAS REVISED TO A MEDACTA ACETABULAR SHELL D 52 MULTI-HOLE AND FLAT PE HC LINER D 36/E. PRESENTLY, ON (B)(6), 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLAT PE HC LINER D 36/E TO A DOUBLE MOBILITY HC LINER D 28/DMC WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25747753 ↗InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD HIP INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA OR BONE QUALITY ISSUES REPORTED. AT ABOUT 1 YEAR AND 9 MONTHS POST PRIMAR THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER. THE SURGEON ALSO REVISED THE 32 MM BIOLOX HEAD M TO A 36 MM BIOLOX HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 25729356 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
AFTER PRIMARY SURGERY ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO INFECTION. A PUNCTURE/ASPIRATION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2026.
Patient problems: Medical device site infection
MAUDE report 25442531 ↗InjuryJun 9, 2026Osseointegration Problem
AT ABOUT 20 DAYS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA OR A FALL. THE SURGEON REVISED THE AMISTEM-P SIZE00 TO A LAT. SIZE0, THE BIOLOX HEAD TO A SAME-SIZE HEAD, THE MPACT D 50 MULTI-HOLE CUP TO A D 54 CUP, AND THE FLAT PE HC LINER D 36/E TO A D 36/F LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 25442528 ↗InjuryMay 20, 2026Device Dislodged or Dislocated
THIS WAS THE SECOND REVISION FOR PATIENT. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2024. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2025; THE STEM WAS REVISED, BUT THE REASON IS UNKNOWN. NO OTHER INFO IS AVAILABLE REGARDING THIS REVISION SURGERY. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISLOCATION OF THE HEAD FROM THE LINER. ALL COMPONENTS REVISED WITH DOUBLE MOBILITY COMPETITOR`S COMPONENT. THE REASON FOR REVISION OF THE FEMORAL STEM IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 25230409 ↗InjuryApr 30, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER ABOUT 11 MONTHS FROM PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE LINER WITH A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25039775 ↗InjuryMar 16, 2026Fracture
THE PATIENT HAD PAIN DUE TO THE ACETABULAR CUP PUSHING INTO THE ACETABULUM CAUSING ACETABULAR PERFORATION. THE SURGEON 2 WEEKS AFTER PRIMARY OBSERVED POOR BONE QUALITY WHICH LED TO THE CUP PUSHING INTO THE BONE. THE SURGEON REVISED THE MEDACTA BIOLOX HEAD TO A MEDACTA COCR HEAD SIZE S AND REVISED THE MEDACTA LINER AND CUP TO A COMPETITOR LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 24603543 ↗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 ↗InjuryMar 10, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION 5 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 32/D LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24558197 ↗
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
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
- GMK Revision Total Knee System71 models · 304 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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