Versafitcup CC TRIO Acetabular System 01.26.3244HCATRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030807565), received between May 15, 2018 and Oct 11, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH POST PRIMARY THE PATIENT WAS REVISED FOR HIP INFECTION. LINER AND HEAD REVISED SUCCESSFULLY. THE SURGEON NOTICED SOME ABRASION LINE IN THE LINER AND A YELLOW COLOURING OF THE POLYETHYLENE.

  Patient problems: Unspecified Infection

  MAUDE report 15575573 ↗
• InjuryDec 17, 2020Microbial Contamination of Device; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY IS PERFORMED ON (B)(6) 2020 (PRIMARY DATE UNKNOWN) DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED THE LINER, HEAD AND CUP BUT AT THIS MOMENT THE LOT NUMBERS ARE UNKNOWN AND PROBABLY MORE INFORMATION WILL NOT BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11026227 ↗
• MalfunctionFeb 22, 2019Difficult to Insert

  DURING THE SURGERY THE SURGEON TRIED THREE TIMES TO INSERT THE LINER IN THE CUP WITHOUT SUCCESS. A NEW INSERT WITH DIFFERENT REFERENCE (REF (B)(4)) WAS USED TO COMPLETE SUCCESSFULLY THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361563 ↗
• MalfunctionDec 14, 2018Device-Device Incompatibility

  IT WAS NOT POSSIBLE TO COUPLE THE INLAY WITH THE CUP. ANOTHER LINER OF THE SAME SIZE, BUT WITH A DIFFERENT LOT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8164779 ↗
• InjuryMay 15, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO IRREDUCIBLE LEFT HIP LUXATION 2 MONTHS AFTER PRIMARY. PERIARTICULAR CALCIFICATIONS FOUND. ALL THE COMPONENTS WERE REVISED. AMIS APPROACH USED IN BOTH PRIMARY AND REVISION.

  Patient problems: Joint Disorder

  MAUDE report 7514382 ↗