Mpact Double Mobility ShellsRecalls & reported problems across all models

We found 9 models of Mpact Double Mobility Shells by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 90 adverse event reports in the FDA's MAUDE database, received between Jul 21, 2017 and Sep 9, 2026 — classified as 85 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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. 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 Double Mobility Shells problems

Mpact Double Mobility Shells models

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

• Mpact Double Mobility Shells 01.32.148MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  23 reports
• Mpact Double Mobility Shells 01.32.150MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  21 reports
• Mpact Double Mobility Shells 01.32.152MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  15 reports
• Mpact Double Mobility Shells 01.32.156MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  8 reports
• Mpact Double Mobility Shells 01.32.158MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  7 reports
• Mpact Double Mobility Shells 01.32.154MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  6 reports
• Mpact Double Mobility Shells 01.32.160MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  5 reports
• Mpact Double Mobility Shells 01.32.162MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• Mpact Double Mobility Shells 01.32.146MB

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports

Recent Mpact Double Mobility Shells adverse event reports

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

• InjurySep 9, 2026Device Dislodged or Dislocated

  At about 2 months from the primary, the patient came in presenting pain due to a dislocation of the liner from the cup and the cause is unknown. The surgeon revised the D 28/DMF liner to a same size liner and revised the 28mm BIOLOX Delta Head S to a CoCr Ball Head 12/14 D 28 mm size XL. The surgery was completed successfully.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 50692308 ↗
• InjuryMay 27, 2026Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PAIN THAT WAS DUE TO A CUP THAT HAD MOVED AND THE CAUSE IS UNKNOWN. THE PATIENT DID NOT ADHERE TO THE FOLLOW-UP APPOINTMENT SCHEDULE AFTER PRIMARY SURGERY. THE SURGEON REVISED THE MPACT DM D 50 CUP TO A MPACT DM D 54 CUP, REVISED THE HC D 28/DME LINER TO A HC D 28/DMG LINER, AND REVISED THE 28MM BIOLOX HEAD TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25297697 ↗
• InjuryNov 21, 2025Malposition of Device; Malposition of Device

  AT ABOUT 2 YEARS 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE REPRESENTATIVE REPORTED THAT THE CUP WAS ANTEVERTED AND THAT THE PATIENT WAS EXPERIENCING IMPINGEMENT. THEY INITIALLY SUSPECTED THE ISSUE WAS DUE TO A LOOSE CUP, BUT UPON FURTHER INSPECTION THE CUP WAS FOUND TO BE WELL FIXED. IT WAS OBSERVED THAT THE ACTUAL PROBLEM WAS MALPOSITION, SPECIFICALLY EXCESSIVE ANTEVERSION. THE SURGEON REVISED MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND MEDACTA HEAD TO A NEW MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement

  MAUDE report 23616979 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS AND 8 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN. FIBROUS INGROWTH WAS FOUND ON THE CUP SIDE. THE SURGEON SWAPPED THE MEDACTA HEAD TO A MEDACTA HEAD AND REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23615350 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN WITH PAIN DUE TO A ANTEVERTED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER. THE SURGEON UPSIZED THE MEDACTA HEAD TO A MEDACTA HEAD WITH A SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23615343 ↗
• InjuryNov 10, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT1 YEAR AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEONREVISED THE LINER, HEAD AND UPSIZED CUP AFTER DETERMINING THAT THE CUP WASMALALIGNED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23510641 ↗
• InjuryOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING HER STAY AT THE REHABILITATION CENTRE (THE PATIENT WAS PREVIOUSLY REVISED DUE TO CHRONIC INFECTION), THE PATIENT SUFFERED A JOINT LUXATION (DM LINER ALONG WITH HEAD DISLOCATED FROM THE CUP) OF HER PROSTHESIS ON (B)(6) 2025, 2 MONTHS AFTER THE PREVIOUS SURGERY. THE CAUSE OF THIS DISLOCATION HAS NOT BEEN CLEARLY IDENTIFIED. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT OF THE NEAREST HOSPITAL. THE REDUCTION WAS PERFORMED IN THE OPERATING THEATRE UNDER GENERAL ANAESTHESIA. ACCORDING TO THE SURGEON ON DUTY, THE REDUCTION WAS EASILY PERFORMED. HOWEVER, FOLLOW-UP X-RAY RAISED DOUBTS ABOUT THE SUCCESS OF THE REDUCTION. ANOTHER SURGEON WAS CONSULTED AND HE CONCLUDED THAT X-RAYS SHOWED A DISSOCIATION BETWEEN THE DM LINER AND HEAD. AN EMERGENCY REVISION WAS PERFORMED ON (B)(6) 2025 BY THE CONSULTED SURGEON. AFTER INCISION, A LARGE HAEMATOMA WAS DRAINED AND IT WAS CONFIRMED THAT THE INSERT HAD BECOME DETACHED FROM THE HEAD. IT WAS FOUND TO BE ALMOST SUBCUTANEOUS. DM LINER AND HEAD REPLACED. IT IS CONFIRMED THAT THE DISSOCIATION BETWEEN THE DM LINER AND THE HEAD HAPPENED ONLY AFTER THE CLOSED REDUCTION. REGARDING THE JOINT DISLOCATION, THE SURGEON REPORTED THAT THE HEMATOMA MAY HAVE

  Patient problems: Joint Dislocation

  MAUDE report 23367258 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO PAIN FROM THE ANTEVERTED CUP. AT ABOUT 9 MONTHS POST PRIMARY, THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22337284 ↗
• InjuryMay 12, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22000384 ↗
• InjuryJan 2, 2025Migration; Migration

  AT ABOUT 2 YEARS AND 7 MONTHS FROM 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21053560 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  AT ABOUT 1 YEAR AND 3 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO AN ANTEVERTED CUP RESULTING FROM A MOBILIZATION OF UNKNOWN CAUSE AFTER AN INITIAL GOOD POSITIONING. THE SURGEON REVISED THE CUP AND DM CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20911055 ↗
• InjuryOct 29, 2024Osseointegration Problem; Osseointegration Problem

  THE DAY AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20555178 ↗
• InjuryOct 24, 2024Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN. UPON EXPLORATION, THE SURGEON OBSERVED POOR CUP PLACEMENT. ABOUT 3 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, LINER AND HEAD. CUP WAS WELL FIXED, IT WAS PROBABLY MALPOSITIONED DURING PRIMARY, BUT THIS CANNOT BE CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20522022 ↗
• InjuryOct 23, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD HIP INSTABILITY AND THE CAUSE WAS UNKNOWN. AT ABOUT 5 YEARS AND 1 MONTH POST PRIMARY UPON OPENING THE PATIENT, IT WAS OBSERVED THAT THE CUP WAS LOOSE AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 20512683 ↗
• InjuryOct 2, 2024Malposition of Device; Malposition of Device

  AT ABOUT 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED CUP FROM THE PRIMARY SURGERY. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20351521 ↗

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