Versafitcup CC TRIO Acetabular System 01.26.2839HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030807091), received between Aug 3, 2017 and May 7, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2022Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PAIN IN THE HIP AND FROM THE X-RAY THE SURGEON DETERMINED THAT THE INLAY WAS NOT CENTRAL ANYMORE. AT 16 YEARS FROM PRIMARY THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14317030 ↗
• InjuryApr 6, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 YEARS AND 6 MONTHS AFTER PRIMARY FOR HIP ANTERIOR LUXATION. THE SURGEON REVISED SUCCESSFULLY THE CUP, INLAY AND HEAD WITH DOUBLE MOBILITY VERSACEM AND BIOLOX OPTION 28 XL.

  Patient problems: Joint Dislocation

  MAUDE report 11618156 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem

  THE SURGEON DISCOVERED AN INFECTION 3 YEARS AFTER THE PRIMARY SURGERY (THE PATHOGEN IS UNKNOWN) AND DECIDED TO REMOVE ALL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 10136934 ↗
• InjuryMar 21, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 9 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO ECCENTRICITY OF THE HEAD. IT WAS ALSO FOUND ACETABULAR AND PROXIMAL FEMUR OSTEOLYSIS. SUSPECTED LINER ABRASION. HEAD AND LINER SUCCESSFULLY REVISED.

  Patient problems: Joint Disorder

  MAUDE report 9863307 ↗
• MalfunctionJul 30, 2019Difficult to Insert; Difficult to Insert

  THE LINER DOESN'T ENTER IN THE CUP, THE SURGERY WAS COMPLETED USING ANOTHER IMPLANT. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8840206 ↗
• MalfunctionJul 31, 2018Difficult to Insert

  DURING THE SURGERY THE INSERT DIDN'T COUPLE THE CUP. THE SURGEON IMPLANTED SUCCESSFULLY A NEW LINER OF THE SAME REFERENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734716 ↗
• InjuryAug 3, 2017Fracture; Naturally Worn

  REVISION OF THE INLAY AND THE HEAD BECAUSE OF A WORN OUT INLAY AFTER 11 YEARS. THE PATIENT HAD A FIRST REVISION 4 DAYS AFTER PRIMARY DUE TO A FRACTURED CERAMIC LINER: Ø28 LINER PE, COCR 28 HEAD WERE PUT IN.

  Patient problems: No Code Available

  MAUDE report 6762727 ↗