Versafitcup CC TRIO Acetabular System 01.26.45.1150Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030807886), received between Dec 7, 2017 and Dec 23, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO SHELL LOOSENING AT 6 MONTHS POST OP.

  Patient problems: Aseptic loosening

  MAUDE report 23876947 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 2 YEARS FROM PRIMARY FOR HIP INFECTION. ALL DEVICES REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17413517 ↗
• InjuryApr 6, 2022Appropriate Device Problem Term/Code Not Available

  ALL IMPLANTS WERE REVISED 1 YEAR AFTER PRIMARY FOLLOWING A LOW-GRADE INFECTION. AN ANTIBIOTIC SPACER HAS BEEN IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14019807 ↗
• InjuryDec 7, 2021Output Problem

  AT 7 YEARS 8 MONTHS, THE SURGEON REVISED ALL IMPLANTS DUE TO MOBILIZATION OF THE STEM AND SHELL CAUSED BY GRANULOMA. THE CAUSE OF GRANULOMA IS UNKNOWN.

  Patient problems: Granuloma

  MAUDE report 12950769 ↗
• InjuryMay 20, 2021Malposition of Device; Malposition of Device

  THE PATIENT ALREADY LUXATED TWICE, DUE TO TOO MUCH ANTEVERSION AND INCLINATION OF THE CUP. 1 MONTH AFTER THE PRIMARY SURGERY THE SURGEON DECIDED TO REVISE THE ACETABULAR COMPONENTS AND THE FEMORAL HEAD.

  Patient problems: Joint Laxity

  MAUDE report 11854199 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY 1 YEAR AFTER PRIMARY FOR HIP PAIN DURING WALKING. ALL IMPLANT REVISED SUCCESSFULLY. THE REASON OF PAIN IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11641923 ↗
• InjuryJun 14, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 8 MONTHS FROM THE REVISION DUE TO PAIN (NO BONE FRACTURE, NO STEM LOOSENING DESPITE RADIOLUCENCIES). IT WAS IMPOSSIBLE TO EXTRACT THE STEM USING THE STEM EXTRACTOR (KALBERER) AND THE SURGEON DECIDED TO LEAVE THE STEM IN PLACE. THE CERAMIC BALL HEAD, ACETABULAR SHELL, AND LINER HAVE BEEN REVISED.

  Patient problems: Pain

  MAUDE report 8699595 ↗
• InjuryMay 29, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1,5 YEARS FROM THE PRIMARY DUE TO A SEPTIC INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY: ABLATION OF THE ACETABULUM AND THE LINER. THE SURGEON COULDN'T REMOVE THE STEM (DESPITE THE USING OF THE EXTRACTOR) HE DECIDED TO LEAVE IT IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 8649829 ↗
• InjuryApr 4, 2019Loose or Intermittent Connection

  PATIENT HAD SYMPTOMS OF HIP PAIN 6 WEEKS AFTER THE PRIMARY SURGERY. X-RAYS SHOWED THE STEM LOOSENING AND THE BIOPSY SHOWED SIGNS OF INFECTION. ALL COMPONENTS WERE REMOVED, 3 MONTHS AFTER PRIMARY. WE DO NOT HAVE ANY DETAIL CONCERNING THE HEAD AND LINER, THE STEM WAS FROM A COMPETITOR COMPANY.

  Patient problems: Unspecified Infection

  MAUDE report 8482791 ↗
• MalfunctionOct 3, 2018Component Missing; Component Missing

  DURING SURGERY, THE SURGICAL STAFF OPENED THE PACKAGING OF THE ACETABULAR SHELL CC TRIO NO-HOLE AND DISCOVERED THAT NO IMPLANT WAS INSIDE THE CARTON BOX, NOT EVEN THE STERILE PLASTIC BLISTERS OF THE IMPLANT. ONLY THE IFU OF THE IMPLANT WERE FOUND INSIDE THE CARTON BOX.. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SECOND CUP OF THE SAME SIZE AVAILABLE ON THE CONSIGNMENT STOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7929603 ↗
• InjuryApr 20, 2018Contamination

  REVISION SURGERY DUE TO INFECTION WITH PROPIONI BACTERIA 3 YEARS AFTER PRIMARY.

  Patient problems: Unspecified Infection

  MAUDE report 7446809 ↗
• MalfunctionDec 7, 2017Device Issue; Device Issue

  ACCORDING TO THE SURGEON AND THE OR STAFF, THE CONNECTION HOLE OF THE VERSAFICTUP CC TRIO NO-HOLE 50 WAS NOT CENTRAL IN THE CUP. THE INVOLVED CUP WAS NOT USED AND ANOTHER ONE WAS OPENED, SAME REFERENCE BUT DIFFERENT LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7095626 ↗