Versafitcup CC TRIO Acetabular System 01.26.45.1152Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030807893), received between Jul 20, 2018 and Sep 22, 2021 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjurySep 22, 2021Malposition of Device; Malposition of Device

  LUXATION DUE TO TOO MUCH ANTEVERSION OF THE CUP. HEAD AND LINER SUCCESSFULLY REVISED 2 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12512821 ↗
• InjuryJun 10, 2020Loosening of Implant Not Related to Bone-Ingrowth

  LOOSE CUP HAS BEEN IDENTIFIED THROUGH A SPECT CT, WHERE THE AREA AT THE CUP WAS BRIGHT. REVISION CONFIRMED LOOSENESS. INFECTION HAS BEEN DETECTED INTRAOPERATIVELY (UNKNOWN PATHOGEN), ALTHOUGH PUNCTATION A WEEK EARLIER SHOWED NO INFECTION. SURGEON PROCEEDED EXPLANTING ALL COMPONENTS LEABING GIRDLESTONE HIP TEMPORARILY.1 YEAR AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 10137535 ↗
• InjuryJun 10, 2020Unstable; Patient-Device Incompatibility

  THE PATIENT COMPLAINED PAIN AND INSTABILITY. IT WAS NOTICED THAT THERE WAS NO BONDING BETWEEN THE CEMENT AND THE FEMORAL AND TIBIAL IMPLANT. THE CEMENT IN PLACE WAS FROM COMPETITOR. 1 YEAR AND 1 MONTH AFTER PRIMARY THE REVISION SURGEON REVISED ALL THE IMPLANTS SUCCESSFULLY AND STATED THAT THE FEMUR IMPLANT WAS OVERSIZED FOR THE PATIENT KNEE. PRIMARY SURGEON WAS NOT THE REVISION SURGEON. A HINGE COMPETITOR SYSTEM WAS IMPLANTED.

  Patient problems: Joint Disorder

  MAUDE report 10137534 ↗
• InjuryJun 10, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR STEM AND CUP LOOSENING ABOUT 11 YEARS AFTER PRIMARY SURGERY. RADIOLUCENCY WAS PRESENT WITHOUT A MECHANICAL CAUSE. NO INFECTION DETECTED.

  Patient problems: Joint Disorder

  MAUDE report 10137533 ↗
• MalfunctionMay 14, 2019Mechanical Problem

  AFTER IMPACTING THE CUP, THE SURGEON COULD NOT REMOVE THE STRAIGHT CUP IMPACTOR. HE HAD TO TAKE THE IMPLANT OUT AND TO USE BACK-UP CUP WITH A BACK-UP INSTRUMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8607924 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem

  A FEW MONTH AFTER THE UNDERTAKEN PRIMARY THA, THE PATIENT WAS COMPLAINING ABOUT REMAINING PAIN. AFTER INVESTIGATION A LOW-GRADE INFECTION WAS DIAGNOSED (STAPH EPIDERMITIS). ON (B)(6) 2018, ALL PRIMARY HIP COMPONENTS HAVE BEEN REVISED. DURING THE EXPLANTATION A CHISEL WAS USED ON THE LATERAL SIDE IN ORDER TO RELEASE THE CUP; SOME HA COATING REMAINED IN THE ACETABULUM WHICH COULD BE REMOVED AFTERWARDS. THERE WAS NO PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 8211949 ↗
• MalfunctionJul 20, 2018Insufficient Device Problem Information

  BEFORE THE STERILE CUP WAS OPENED, THE MEDICAL STAFF FOUND A HAIR INSIDE THE BLISTER. THE OPERATION WAS CARRIED OUT WITH THE SAME CUP SIZE, DIFFERENT LOT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7706374 ↗