Mpact Double Mobility Shells 01.32.152MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030860973), received between Jan 17, 2019 and Sep 9, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT 1 WEEK FROM PRIMARY, SHELL, HEAD AND LINER REVISED SUCCESSFULLY. THE PATIENT LUXATED HIS HIP AND SUSTAINED A CLOSED REDUCTION, BUT AFTER THIS, IN THE X-RAYS DONE IN THE ER, IT WAS NOTICED THAT THE SHELL WAS OUT OF THE ACETABULUM BONE. IT IS UNKNOWN IF THE LUXATION WAS DUE TO THE CUP FAILURE OR IF THE CUP FAILURE WAS GENERATED DURING THE CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 19749121 ↗
• InjurySep 28, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 4 MONTHS AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17834519 ↗
• InjuryJun 16, 2023Malposition of Device; Malposition of Device

  AT ABOUT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON OBSERVED THAT THE PATIENT HAD A MALPOSITIONED CUP AND THE CAUSE OF THE MALPOSITIONING IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 17144072 ↗
• InjuryMar 30, 2023Malposition of Device; Malposition of Device

  AT ABOUT 1 MONTH AFTER THE PRIMARY, DISLOCATION OF THE HEAD FROM THE CUP FOLLOWING MALPOSITIONING OF THE CUP. PATIENT REOPERATED TO MODIFY THE POSITION OF THE CUP WITHOUT DEVICE CHANGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643813 ↗
• InjuryFeb 14, 2022Migration; Migration

  AFTER THE PRIMARY HIP SURGERY, WHEN THE PATIENT WAS IN RECOVERY, IT WAS OBSERVED ON X-RAYS THAT THE CUP HAD MOVED DUE TO POOR BONE QUALITY. THE SURGEON BROUGHT THE PATIENT BACK INTO SURGERY AND REVISED THE CUP, HEAD, AND LINER THE SAME DAY OF PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 13523869 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT SENT AN E-MAIL TO MEDACTA REPORTING THE DETAILS OF THE REVISION SURGERY 1 YEAR AND 1 MONTH AFTER THE PRIMARY AND A COMPLAINT HAS BEEN NOTIFIED. THE SURGEON FOUND NOTABLE METALLOSIS IN THE SYNOVIUM AND INFLAMMATION DUE TO IMPACTION OF THE METALLIC TITANIUM FEMORAL NECK AGAINST THE EDGE OF THE CUP. THERE WAS A NOTCH THAT HAD BEEN BORED INTO THE FEMORAL NECK BECAUSE OF THIS PROSTHETIC IMPINGEMENT.

  Patient problems: Inflammation

  MAUDE report 12474807 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY AND AN ANTEVERTED CUP (FOR UNKNOWN REASONS). 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD, CUP AND LINER AND REPLACED THEM WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 12364560 ↗
• InjuryMay 6, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 YEAR AND 5 MONTHS AFTER PRIMARY FOR REASON UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL DEVICES REVISED. NO FURTHER INFORMATION ARE AVAILABLE FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782733 ↗
• InjuryAug 19, 2019Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED AFTER 4 DAYS FROM THE PRIMARY DUE TO PAIN CAUSED BY A DISLOCATION OF THE LINER FROM THE DM SHELL. THE PATIENT DISLOCATED DUE TO AN AMPUTATED LEFT PELVIS AND LEG. THE SURGEON REVISED THE LINER, CUP AND THE HEAD

  Patient problems: Joint Dislocation

  MAUDE report 8906040 ↗
• InjuryJan 17, 2019Loose or Intermittent Connection; Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility

  THE PATIENT CAME IN, 1 YEAR AND 3 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A LOOSE CUP. THE SURGEON REVISED THE CUP, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8256603 ↗