Mpact Double Mobility Shells 01.32.148MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030860959), received between Nov 24, 2017 and Nov 10, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 5 MONTHS AND A HALF FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO IMPINGEMENT BY THE CUP. THE SURGEON REVISED THE 48MM CUP WITH A 52MM CUP AND ADDED MORE INCLINATION. THE SURGEON ALSO REVISED THE HEAD AND LINER AND ADDED A BIOLOX OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18355544 ↗
• InjuryJul 26, 2023Malposition of Device; Malposition of Device

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

  Patient problems: Pain

  MAUDE report 17396951 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE PRIMARY HIP SURGERY, IN POST-OP RECOVERY WHEN X-RAYS WERE TAKEN, IT WAS OBSERVED THAT THE CUP HAS NOT CORRECTLY SEATED. THE SURGEON DECIDED TO REVISE ALL COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 17276833 ↗
• InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY ABOUT 1 MONTH POST PRIMARY FOR INFECTION. THE SURGEON REVISED THE MEDACTA CUP SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16732181 ↗
• InjuryMar 2, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN TO A LOOSE CUP. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16467465 ↗
• InjuryOct 19, 2022Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE SURGEON OBSERVED THAT THE CUP WAS ANTEVERTED. 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: Inadequate Osseointegration

  MAUDE report 15631723 ↗
• InjuryAug 5, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND CUP WITH ADDITIONAL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15174137 ↗
• InjuryNov 15, 2021Appropriate Device Problem Term/Code Not Available

  AT 4 MONTHS AFTER THE PRIMARY SURGERY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12809543 ↗
• InjuryDec 21, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER, 1 YEAR AND 10 MONTHS AFTER THE PRIMARY. THE PATIENT ONLY HAD A MEDACTA CUP AND LINER IMPLANTED DURING THE PRIMARY.

  Patient problems: Unspecified Infection

  MAUDE report 11045450 ↗
• InjuryOct 28, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY 1 YEAR AND 5 MONTHS AFTER PRIMARY FOR CUP LOOSENING. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR DEVICES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10748197 ↗
• InjuryAug 3, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL COMPONENTS 1 MONTH AFTER PRIMARY. AN ANTIBIOTIC SPACER WAS IMPLANTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10354778 ↗
• InjuryJul 7, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. ON (B)(6) 2019, THE SURGEON REVISED THE STEM, HEAD AND LINER. PRESENTLY (1 YEAR AFTER PREVIOUS SURGERY), THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10238597 ↗
• InjuryOct 25, 2019Appropriate Device Problem Term/Code Not Available

  REVISION FOLLOWING A SUSPICION OF INFECTION. ALL IMPLANTS HAVE BEEN REVISED EXCEPT THE CUP 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9237118 ↗
• InjurySep 26, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON DID NOT PROVIDE ANY ADDITIONAL DETAILS. THE REVISION SURGERY WILL TAKE PLACE ON (B)(6) 2019. MORE DETAILS TO FOLLOW ONCE THE REVISION SURGERY HAS BEEN COMPLETED.

  Patient problems: Pain

  MAUDE report 9122616 ↗
• InjuryMar 28, 2019Fracture

  ACETABULUM BONE FRACTURE DISCOVERED WITH POST-OPERATIVE X-RAYS (OSTEOPOROTIC PATIENT) THE SAME DAY OF THE PRIMARY. CONSERVATIVE TREATMENT WITH PARTIAL WEIGHT BEARING HAS BEEN DONE AND IS DOING WELL. NO REVISION SURGERY IS PLANNED AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 8460364 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7365114 ↗
• InjuryMar 2, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 3 MONTHS AFTER PRIMARY. THE CUP WAS LOOSE. THE CAUSE IS UNKNOWN. NO REPORT OF TRAUMA. THE SURGEON REVISED THE CUP, LINER AND HEAD.

  Patient problems: Joint Disorder

  MAUDE report 7309241 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF ILIOPSOAS PAIN DUE TO CUP MOBILIZATION. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7285365 ↗
• InjuryJan 25, 2018Device Slipped

  DURING THE TRIAL REDUCTION THE CUP SPINOUT OF THE ACETABULUM. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER CUP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7218035 ↗
• InjuryDec 20, 2017Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE CUP WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN.

  Patient problems: Joint Disorder

  MAUDE report 7132882 ↗
• InjuryNov 24, 2017Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON THOUGHT THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 7057481 ↗