Mpact Acetabular System 01.32.3652HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07630030812156), received between Mar 27, 2018 and Sep 1, 2026 — classified as 20 injuries, 1 malfunction.

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 18, 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.

• InjurySep 1, 2026Naturally Worn

  Patient problems: Insufficient Information

  MAUDE report 50543234 ↗
• InjuryNov 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20680992 ↗
• InjuryDec 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18371304 ↗
• InjurySep 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S COMPONENTS BUT RETAINED THE MEDACTA MPACT FLAT LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN, DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. A POSTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 17682002 ↗
• InjuryJul 5, 2023Device 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 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17255160 ↗
• InjuryJun 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

  Patient problems: Joint Dislocation

  MAUDE report 17215889 ↗
• InjuryDec 5, 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 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15914674 ↗
• InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

  Patient problems: Joint Dislocation

  MAUDE report 15283209 ↗
• InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A HEMATOMA. AT 1 WEEK POST PRIMARY THE SURGEON EXPLANTED THE HEAD AND LINER AND IN THE PROCESS, THE CUP SPUN OUT. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND CUP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 15037299 ↗
• InjuryOct 29, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER (LOTS: 2012919, 2009615). THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS (LOTS: 2011671,2103129, 2010341, 2100577, 2103731), AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12719879 ↗
• InjuryOct 28, 2021Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12712167 ↗
• InjuryOct 11, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12605472 ↗
• InjurySep 7, 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 PERFORMED A WASHOUT, REMOVED ALL HARDWARE, AND IMPLANTED NEW HARDWARE 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12433068 ↗
• InjurySep 15, 2020Unstable

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

  Patient problems: No Code Available

  MAUDE report 10535332 ↗
• InjurySep 25, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER ALMOST 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9114995 ↗
• InjuryJul 8, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION ABOUT 1 MONTH AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8766615 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem

  THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER DUE TO INFECTION 19 DAYS AFTER PRIMARY SURGERY. THE PATHOGEN IS PSEUDOMONAS.

  Patient problems: Unspecified Infection

  MAUDE report 8150507 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION ABOUT 2 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7637644 ↗
• InjuryApr 5, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7398591 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON PLANS TO SWAP THE POLY. THE DATE OF THE REVISION IS UNKNOWN AT THIS TIME. MORE INFORMATION TO FOLLOW THE CASE.

  Patient problems: Pain

  MAUDE report 7398589 ↗
• MalfunctionMar 27, 2018Fitting Problem

  WHEN THE SURGEON WAS IMPLANTING THE LINER, IT WOULDN'T SEAT. THE SURGEON USED A SECONDARY LINER (SAME REFERENCE, BUT DIFFERENT LOT [174526]) TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. FIVE MINUTES OF DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7372846 ↗