Mpact Acetabular System 01.32.150DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030810763), received between May 15, 2018 and Jan 9, 2024 — classified as 23 injuries.

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

• InjuryJan 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND EXPLANTED THE CUP, LINER AND HEAD. A BIPOLAR HEAD AND BIOLOX HEAD WERE IMPLANTED TO ACT AS A TEMPORARY SPACER AS PART OF THE 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY. PERMANENT IMPLANTS WILL BE PUT IN AT A LATER DATE.

  Patient problems: Unspecified Infection

  MAUDE report 18473115 ↗
• InjurySep 22, 2023Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY FOR MPACT DH MOBILIZATION ABOUT 15 DAYS AFTER THE PRIMARY SURGERY. ACETABULAR COMPONENTS AND HEAD WERE REVISED SUCCESSFULLY. THIS PATIENT HAD AN INTERMEDIATE REVISION (BEFORE THE ONE PERFORMED ON (B)(6) 2023) FOR HIP DISLOCATION (ABOUT 4 DAYS AFTER THE PRIMARY SURGERY), CAUSED BY A LARGE OSTEOPHYTE THAT WAS REMOVED DURING THE REVISION SURGERY; THE HEAD WAS ALSO REVISED WITH A LARGER ONE, WHILE THE CUP AND LINER WERE NOT REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798585 ↗
• InjuryApr 20, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE CUP AND THE CAUSE IS UNKNOWN. ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, 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 16774619 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 9 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13557377 ↗
• InjuryJan 26, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13357644 ↗
• InjuryJan 26, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, LINER HEAD, AND STEM ALMOST 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13356854 ↗
• InjuryAug 3, 2021Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED 1 WEEK AFTER THE PRIMARY DUE TO SUBLUXATION OF THE ACETABULAR SHELL (NOT ENOUGH PRESS FIT).

  Patient problems: Joint Dislocation

  MAUDE report 12266782 ↗
• InjuryAug 2, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 MONTH AFTER PRIMARY DUE TO INFECTION. STAPH EPIDERMIS WAS THE PATHOGEN. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL IMPLANT REVISED SUCCESSFULLY AND TIBIAL SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 12258956 ↗
• InjuryApr 13, 2021Malposition of Device; Malposition of Device

  6 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO THE PATIENT'S CUP BEING TOO VERTICAL AND ANTEVERTED. THE CAUSE OF THE VERTICAL/ANTEVERTED CUP IS UNKNOWN. THE SURGEON DECIDED TO REVISE THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11654730 ↗
• InjuryMar 17, 2021Insufficient Device Problem Information

  THE PATIENT CAME IN REPORTING GROIN PAIN. POST-OP X-RAYS REVEALED LUCENCY AROUND THE ACETABULAR SHELL. 1 YEAR AND 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11506820 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem

  22 DAYS AFTER PRIMARY SURGERY, THE PATIENT WAS DIAGNOSED WITH INFECTION AND ALL THE IMPLANTS HAVE BEEN REMOVED. A CEMENT SPACER WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11047211 ↗
• InjuryNov 30, 2020Osseointegration Problem; Osseointegration Problem

  THE PATIENT PRESENTS WITH GROIN PAIN, 6 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PLANNED TO RELEASE THE PSOAS TENDON TO RELIEVE THE PAIN AND NOTICED THE CUP WAS LOOSE DURING THE SURGERY. CUP LOOSENING IS THE REASON FOR PAIN. HE REVISED THE CUP, LINER AND FEMORAL HEAD.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10920042 ↗
• InjuryNov 18, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING PSOAS TENDONITIS. THE CAUSE OF THE PSOAS TENDONITIS IS UNKNOWN. 2 YEARS AND 5 MONTHS AFTER THE PRIMARY THE SURGEON REVISED THE ACETABULAR COMPONENTS AND THE CERAMIC HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inflammation; Pain

  MAUDE report 10860816 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem

  6 MONTHS AFTER PRIMARY REVISION SURGERY PERFORMED DUE TO INFECTION. LEFT SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10612283 ↗
• InjurySep 17, 2020Adverse 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 COMPONENTS AND REVISED WITH A COMPETITOR'S SYSTEM 16 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10546260 ↗
• InjuryMay 20, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SHIFTED CUP, AND THE CAUSE OF THE SHIFTED CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND POLY 2 MONTHS AFTER PRIMARY. THE STEM WAS LEFT IN PLACE AS IT APPEARED TO BE STABLE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10073841 ↗
• InjuryJan 31, 2020Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY IN THE HIP. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED, 2 WEEKS AFTER PRIMARY SURGERY, THE HEAD, CUP, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9652067 ↗
• InjuryJan 17, 2020Loose or Intermittent Connection

  ACETABULAR CUP LOOSENING UNKNOWN CAUSE, DUE TO MOBILIZATION THERE WAS AN IMPINGEMENT CUP- STEM. CUP, HEAD AND LINER WERE REVISED ALMOST 3 YEARS AND 3 WEEKS AFTER PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 9601763 ↗
• InjuryMay 17, 2019Fracture; Unstable

  DURING THE PRIMARY HIP SURGERY, THE 50MM 2-HOLE CUP WAS FOUND TO BE UNSTABLE AFTER IT WAS IMPLANTED. THE SURGEON REMOVED THE CUP AND UPON FURTHER EXAMINATION, A FRACTURE WAS DISCOVERED IN THE SUPERIOR ACETABULAR WALL. THE SURGEON RE-IMPLANTED THE CUP AND INSERTED A 6.5 X 30MM DOME SCREW IN THE FIRST HOLE. THE SURGEON DETERMINED THAT A 6.5 X 30MM DOME SCREW COULD NOT BE INSERTED INTO THE SECOND HOLE DUE TO THE FRACTURE. THE 50MM 2-HOLE CUP AND 6.5 X 30MM SCREW WERE THEN REMOVED AND A 52MM MULTI-HOLE CUP AND 3 DOME SCREWS WERE IMPLANTED AS THIS ALLOWED FOR MORE SCREW HOLE OPTIONS. THE 52MM CUP WAS STABLE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON FOR THE BREAKAGE IS PROBABLY THE SIZER THAT WOULDN'T FULLY SEAT AND THE SURGEON HIT THE HANDLE HARDER, WHICH MAY HAVE CAUSED THE CRACK.

  Patient problems: Hip Fracture

  MAUDE report 8619678 ↗
• InjuryAug 22, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN 3 MONTHS AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE CUP WAS LOOSE.

  Patient problems: Pain

  MAUDE report 7804983 ↗
• InjuryMay 24, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2017. IN (B)(6) 2017 CAME IN DUE TO SIGNS OF INFECTION AND THE SURGEON PERFORMED AN I&D AND SWAPPED THE HEAD AND LINER. THE PATHOGEN IS UNKNOWN. (B)(4). ON (B)(6) 2018 THE PATIENT IS BEING REVISED FOR INFECTION [STAPHILOCOCCUS]. THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED A SPACER CONTAINING A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7540699 ↗
• InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF GROIN PAIN 6 MONTHS AFTER THE PRIMARY. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGEON USED ANOTHER COMPANY'S CUP AND LINER WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7522297 ↗
• InjuryMay 15, 2018Device Slipped

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT 1 YEAR AFTER PRIMARY. THE PATIENT ALSO HAD A LOOSE STEM. IT IS UNKNOWN IF THE POTENTIAL INFECTION CAUSED THE LOOSENING. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN INVOLVED IS STAPHYLOCOCCUS EPIDERMIDIS.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 7514386 ↗