Mpact Double Mobility Shells 01.32.150MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07630030860966), received between Mar 16, 2018 and May 27, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryAug 28, 2024Osseointegration Problem; Osseointegration Problem

  AT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20088978 ↗
• InjuryNov 10, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 1 YEAR FOR SHELL LOOSENING. THE SHELL, LINER AND HEAD HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18109427 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO IMPINGEMENT BETWEEN CUP AND STEM CAUSING PAIN AND INSTABILITY. THE SURGEON REVISED THE HEAD (S TO XL) AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17753999 ↗
• InjuryFeb 3, 2023Positioning Problem; Positioning Problem

  AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE CUP WAS TOO VERTICAL. THE CAUSE OF THIS 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 16291933 ↗
• InjuryOct 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO CUP IMPINGING ANTERIORLY. 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: Pain

  MAUDE report 15543147 ↗
• InjurySep 19, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15444692 ↗
• InjuryJul 1, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS OF THE JOINT, THE CAUSE IS UNKNOWN. THE STEM WAS SOLID AND WELL FIXED, SO THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISE THE HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14883686 ↗
• InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A CUP IMPINGEMENT, THERE WAS A LOT OF TISSUE SURROUNDING THE CUP. AT 7 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE MEDACTA CUP TO A COMPETITOR CUP AND REVISED THE MEDACTA HEAD AND LINER TO A MEDACTA HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14344591 ↗
• InjuryJul 1, 2021Appropriate Device Problem Term/Code Not Available

  1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO A CUP IMPINGEMENT WITH THE GREATER TROCHANTER CAUSED DUE TO THE CUP SHIFTED. THE SURGEON REVISED THE CUP, HEAD, AND LINER.

  Patient problems: Insufficient Information

  MAUDE report 12098251 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER, 5 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11284520 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT WAS EXPERIENCING TISSUE BREAKDOWN DUE TO AN INFECTION. THE SURGEON REVISED THE HEAD WITH SLEEVE, CUP AND LINER. THE PATHOGEN IS UNKNOWN AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10366572 ↗
• InjuryDec 4, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 2 YEARS AND 1 MONTH AFTER THE PRIMARY DUE TO PAIN CAUSED BY A CUP IMPINGEMENT WITH ILIOPSOAS TENDON. THE CAUSE OF THE CUP IMPINGEMENT IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP, LINER AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO METALOSIS WAS PRESENT.

  Patient problems: Joint Disorder

  MAUDE report 9410176 ↗
• InjuryNov 6, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A CUP THAT HAD NOT INGROWN PROPERLY. THE SURGEON REVISED THE ACETABULAR SHELL AND THE LINER WITH COMPETITOR PRODUCTS, ALMOST 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9283645 ↗
• InjurySep 11, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN 7 MONTHS AFTER PRIMARY, THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A COMPETITOR'S PRODUCTS INTO THE PATIENT.

  Patient problems: Pain

  MAUDE report 8987628 ↗
• InjuryJan 17, 2019Appropriate Device Problem Term/Code Not Available

  ON DEC 18, 2018 WE WERE INFORMED THAT A PATIENT HAD PAIN CAUSED BY PSOAS IMPINGEMENT 1 YEAR AND 1 MONTH AFTER PRIMARY. ON (B)(6) 2018 THE SURGEON REVISED THE CUP, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8256607 ↗
• InjuryApr 10, 2018Fracture

  REVISION SURGERY PERFORMED DUE TO ACETABULAR MEDIAL WALL FRACTURE 3 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE CUP AND LINER.

  Patient problems: Hip Fracture

  MAUDE report 7412282 ↗
• InjuryMar 16, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7344706 ↗