Versafitcup CC TRIO Acetabular System 01.26.3244HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630030807572), received between Sep 6, 2017 and May 7, 2025 — classified as 16 injuries, 3 malfunctions.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING SURGERY THE SURGEON COULD NOT COUPLE THE LINER WITH THE CUP. AFTER MULTIPLE ATTEMPTS A NEW IMPLANT WAS OPENED WHICH CLIPPED SUCCESSFULLY. 30 MINUTES OF DELAY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975575 ↗
• InjuryApr 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REVISION SURGERY PERFORMED DUE TO PAIN AT ABOUT 10 YEARS FROM THE PRIMARY SURGERY. LINER AND BALL HEAD REVISED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21932981 ↗
• InjuryDec 12, 2024Degraded; Degraded

  REVISION SURGERY PERFORMED AT ABOUT 14 YEARS 5 MONTHS AFTER THE PRIMARY FOR UNKNOWN REASON. THE SURGEON REVISED THE LINER AND HEAD. SOME WEAR OF THE PE COMPONENT IS VISIBLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20911253 ↗
• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  AT ABOUT 10 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF CYST RESORPTION PROBABLY CAUSED BY PE LINER WEAR. THE LINER HAS BEEN SUCCESSFULLY REVISED.

  Patient problems: Cyst(s)

  MAUDE report 19719230 ↗
• InjuryJul 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 8 YEARS AND 3 MONTHS POST PRIMARY, REVISION SURGERY FOR HIP LUXATION. LINER AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17265750 ↗
• MalfunctionJun 15, 2022Difficult to Insert

  IT WAS NOT POSSIBLE TO INSERT THE VERSAFITCUP PE HC LINER E 32MM IN THE VERSAFITCUP 52MM. THE SURGEON TRIED 2 LINERS AND IT WAS EITHER NOT POSSIBLE. AFTERWARD, HE IMPLANTED THE 54MM VERSAFIT AND WITH THIS CUP, IT WAS POSSIBLE TO INSERT THE SAME LINER. AT LEAST 30 MINUTES OF DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694831 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem

  LUXATED HIP PROSTHESIS. REVISION SURGERY PERFORMED 5 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY. HEAD AND LINER REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 13558377 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  INFECTION AFTER WOUND HEALING DISORDER. HEAD AND LINER REVISED 2 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 13469560 ↗
• InjurySep 10, 2021Device Dislodged or Dislocated

  REVISION SURGERY PLANNED FOR (B)(6) 2021 DUE TO DISLOCATION OF THE HEAD FROM THE LINER. THE PRIMARY DATE IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE AT THIS MOMENT.

  Patient problems: Joint Dislocation

  MAUDE report 12452400 ↗
• InjuryMar 11, 2021Device Dislodged or Dislocated

  REVISION SURGERY DUE TO DISLOCATION OF THE HEAD FROM THE LINER 1 MONTH AFTER THE PRIMARY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 11463080 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS A LOW GRADE INFECTION WITH STAPHYLOCOCCUS EPIDERMIDIS. 7 MONTHS AFTER PRIMARY THE SURGEON EXPLANTED SUCCESSFULLY ALL THE DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 10482178 ↗
• InjuryApr 29, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 2 YEARS AND 5 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10008491 ↗
• InjuryApr 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ON THE (B)(6) 2020 DUE TO INFECTION, THE SURGEON CHANGED THE INLAY AND HEAD. HEAD WAS NOT A MEDACTA PRODUCT. PRIMARY DETAILS ARE UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 9919753 ↗
• InjuryFeb 14, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION. ONLY THE INLAY HAS BEEN CHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9710854 ↗
• InjuryOct 30, 2019Appropriate Device Problem Term/Code Not Available

  DURING A FOLLOW UP, THE SURGEON DISCOVERED THAT THE PATIENT HAD SUBCUTANEOUS STORAGE AREA WITH DEEDING OF THE WOUND ON THE DISTAL PART AND IMBIBITION OF TISSUES AND REDDENING. FEW DAYS LATER THE PATIENT WAS REVISED, LINER AND HEAD WERE REMOVED, PROBABLY DUE TO INFECTION, PATHOGEN IS STAPHYLOCOCCUS AUREUS. THE REVISION HAS BEEN PERFORMED 20 DAYS AFTER PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 9255107 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TWO TIMES ((B)(6) 2018) DUE TO HIP DISLOCATION, 4 AND 5 MONTHS AFTER PRIMARY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8235402 ↗
• InjuryNov 13, 2018Appropriate Device Problem Term/Code Not Available

  PATIENT RETURNED TO HOSPITAL WITH POSSIBLE INFECTION 9 MONTHS AFTER PRIMARY SURGERY. HIP WASHOUT WAS PERFORMED AND NO INFECTION DETECTED. BEARING SURFACES REVISED TO PROVIDE NEW ARTICULATING SURFACES.

  Patient problems: Joint Disorder

  MAUDE report 8064116 ↗
• MalfunctionDec 28, 2017Device Issue; Device Issue

  THE INLAY DID NOT FIT INTO THE CUP, THE SIZE WAS CORRECT. AFTER A FEW TIMES TRYING, A NEW PE LINER E WAS OPENED AND IT WORKED.

  Patient problems: No Information

  MAUDE report 7150720 ↗
• InjurySep 6, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTION AND THE SURGEON DECIDED TO TAKE OUT THE PLATE, CHANGE THE MOBILE PARTS OF THE PROSTHESIS (LINER AND HEAD) AND REPLACE ANOTHER PLATE. THE SURGEON REVISED THE INSERT LINER AND REPLACED THE CERAMIC HEAD WITH A CRCO BALL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6844649 ↗