Mpact Acetabular System 01.32.148DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030810732), received between Nov 29, 2017 and May 8, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT 1 YEAR FROM 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: Inadequate Osseointegration

  MAUDE report 19267219 ↗
• InjuryJan 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS NOT POSSIBLE TO COUPLE THE POLY LINER TO THE CUP. ATTEMPTING TO INSERT THE LINER THE CUP DISSOCIATED FROM THE ACETABULUM AND A SLIGHT FRACTURE WAS GENERATED. SURGERY FINISHED WITH A CUP OF INCREASED SIZE AND ACETABULAR SCREWS. NO FRACTURE FIXATION WAS NEEDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 18452644 ↗
• InjuryJul 25, 2023Failure to Osseointegrate; Failure to Osseointegrate

  ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17389615 ↗
• InjuryFeb 15, 2023Failure to Osseointegrate; Device Dislodged or Dislocated; Failure to Osseointegrate; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY DUE TO THE DISLOCATION OF THE HEAD FROM THE LINER. DURING THE REVISION, THE CUP WAS FOUND TO BE LOOSE. IT IS LIKELY THAT THE LOOSENESS OF THE CUP CAUSED THE JOINT LUXATION. CUP, HEAD, LINER, AND STEM REVISED SUCCESSFULLY. THE STEM WAS REVISED ONLY TO BE ABLE TO REVISE THE CUP.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 16378891 ↗
• InjuryNov 30, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 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 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 15885777 ↗
• InjuryOct 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15692444 ↗
• InjuryJul 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE HIP STABILITY CHECK THE 48MM CUP SPUN OUT OF THE ACETABULUM. THE SURGEON REAMED THE BONE TO 50MM, IMPLANTED A 50MM IMPACT SHELL AND ADDED 2 SCREWS COMPLETING THE SURGERY SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15037412 ↗
• InjuryMay 5, 2021Malposition of Device; Malposition of Device

  7 MONTHS AFTER THE PRIMARY SURGERY THE CUP, LINER, BALL HEAD AND SCREWS WERE REVISED DUE TO RECURRENT DISLOCATIONS(HEAD FROM THE LINER) AND MALPOSITIONED CUP(IT WAS TOO RETROVERTED) WHAT MAY HAVE CONTRIBUTED TO THE DISLOCATIONS.

  Patient problems: Failure of Implant

  MAUDE report 11775803 ↗
• InjurySep 9, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING INSTABILITY 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE CUP AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 10507113 ↗
• InjuryApr 29, 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 IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER ALMOST 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETE SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10009077 ↗
• InjuryJun 27, 2019Material Deformation; Material Deformation

  THE SURGEON WAS NOT ABLE TO ENGAGE THE MPACT CUP WITH THE CUP IMPACTOR CORRECTLY (NOT STRAIGHT). THE SURGEON ENGAGED THE THREAD PART OF THE INSTRUMENT WITH THE IMPLANT AND TRIED TO IMPACT, BUT HE WAS NOT ABLE TO SET THE MPACT CUP CORRECTLY. THE SURGEON USED A BIGGER CUP (SAME SIZE CUP NOT AVAILABLE) AND A NEW CUP IMPACTOR COMPLETING SUCCESSFULLY THE SURGERY. THE EVENT CAUSED 30 MINUTES OF DELAY IN THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739673 ↗
• InjuryNov 9, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A PROBABLE EARLY POST PRIMARY MOBILIZATION OF THE CUP SUCCESSIVELY BECOME VERY SOLID WITH PLENTY OF BONY IN-GROWTH. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8054893 ↗
• InjuryOct 3, 2018Loose or Intermittent Connection

  ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR CUP LOOSENING. THE PATIENT WAS SUFFERING FROM IMPINGEMENT AND THAT AS THE PATIENT FLEXED HER HIP, SHE WAS HINGING OFF THE EDGE OF THE CUP. THE SURGEON BELIEVED THIS MAY HAVE CONTRIBUTED TO THE CUP LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7929614 ↗
• InjuryMar 14, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF DISLOCATION 4 MONTHS AFTER PRIMARY. THE SURGEON BELIEVES THERE WAS TOO MUCH ANTEVERSION FROM THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7338232 ↗
• InjuryNov 29, 2017Device Dislodged or Dislocated

  REVISION SURGERY DUE TO SUBLUXATION DURING FLEXION 8 MONTHS AFTER PRIMARY, PROBABLY DUE TO RETROVERTED CUP. THE SURGEON REVISED THE CUP AND LINER.

  Patient problems: Joint Disorder

  MAUDE report 7067346 ↗