Mpact Double Mobility Shells 01.32.154MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030860980), received between May 16, 2019 and Nov 21, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE CUP FOLLOWING FRACTURED ACETABULUM. THE SURGEON CABLED THE FRACTURE AND REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15932906 ↗
• InjurySep 14, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE CUP. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SAME DAY OF THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, HEAD, LINER AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12467146 ↗
• InjuryMay 11, 2021Migration or Expulsion of Device

  REVISION SURGERY 6 MONTHS AFTER PRIMARY DUE TO CUP MIGRATION. ALL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11804821 ↗
• MalfunctionMay 16, 2019Device Slipped; Device Slipped

  DURING THE PRIMARY HIP SURGERY AND AFTER IMPLANTING THE 54MM MPACT DM CUP, THE CUP DISENGAGED AND SPUN OUT WHILE THE HIP WAS TAKEN THROUGH RANGE OF MOTION. THE SURGEON RE-IMPLANTED THE CUP AND IT DISENGAGED AND SPUN OUT AGAIN. THE SURGEON CHOSE TO IMPLANT A 54MM MPACT TWO HOLE CUP AND 2 MPACT DOME SCREWS FOR BETTER FIXATION AND THE CUP WAS STABLE THROUGH RANGE OF MOTION. TRIALS WERE INSERTED AND THE HIP WAS TAKEN THROUGH RANGE OF MOTION. THE TRIALS WERE REMOVED AND PERMANENT IMPLANTS WERE IMPLANTED. THE SURGEON WAS UNABLE TO REDUCE THE HIP AFTER MULTIPLE ATTEMPTS AND DECIDED TO REMOVE THE 36MM BIOLOX DELTA HEAD L. A 36MM BIOLOX DELTA HEAD M WAS IMPLANTED AND THE SURGEON WAS ABLE TO REDUCE THE HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY REMOVING ALL COMPONENTS EXCEPT FOR THE STEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615718 ↗