Versafitcup CC TRIO Acetabular System 01.26.45.0046Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030807749), received between Dec 6, 2017 and Sep 9, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  At about 1 month after the primary THR (performed following a femoral fracture due to a fall), revision surgery was performed due to penetration of the acetabular cup and screws through the acetabulum observed on postoperative X-ray. The cup and screws were easily removed using forceps, without a screwdriver. Pelvic reconstruction was performed, followed by implantation of a competitor`s cemented dual-mobility cup and exchange of the Medacta femoral head. Surgery was completed successfully.

  Patient problems: Bone Fracture(s)

  MAUDE report 50692321 ↗
• InjuryNov 21, 2025Migration; Migration

  REVISION SURGERY AT ABOUT 8 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERYBECAUSE OF DEVELOPMENT OF BONE GRANULOMA AT ACETABULUM BONE LEVEL. THE SHELL WAS MIGRATED FROM ITS ORIGINAL POSITION. THE ETIOLOGY OF THIS DEVELOPMENT IS UNKNOWN. NO INFECTION DETECTED.

  Patient problems: Granuloma

  MAUDE report 23615704 ↗
• InjuryApr 30, 2025Naturally Worn; Osseointegration Problem; Naturally Worn; Osseointegration Problem

  REVISION SURGERY PERFORMED ABOUT 8 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF THE RIGHT CUP. POLYETHYLENE LINER WEAR WAS NOTED WITH SEGMENTAL ACETABULAR DEFECT (SUPRA-ACETABULAR, POSTERIOR COLUMN, AND ILIOPUBIC BRANCH).

  Patient problems: Inadequate Osseointegration

  MAUDE report 21932363 ↗
• InjuryMar 13, 2024Osseointegration Problem; Unintended Movement; Osseointegration Problem; Unintended Movement

  AT 7 YEARS AND 7 MONTHS POST PRIMARY THE CUP PROTRUDED IN THE ACETABULAR WALL LEADING TO CUP DISSOCIATION FROM THE ACETABULAR BONE. THE SURGEON REVISED SUCCESSFULLY ALL THE ACETABULAR COMPONENTS AND THE BALL HEAD.

  Patient problems: Hip Fracture

  MAUDE report 18892728 ↗
• InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 11 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO ASEPTIC ACETABULAR LOOSENING. PAIN DESCRIBED BY THE PATIENT. NO INFECTION. CUP, LINER, HEAD, AND SCREW SUCCESSFULLY REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18844187 ↗
• InjuryFeb 9, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY FOR CUP MOBILIZATION (ASEPTIC LOOSENING) AT ABOUT 1 YEAR AND 5 MONTHS FROM PRIMARY. CUP, LINER AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 16331387 ↗
• InjuryNov 21, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 4 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 15832739 ↗
• InjurySep 12, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, HEAD, LINER, AND SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15400678 ↗
• InjuryMar 17, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO CUP LOOSENING. THE PRIMARY SURGERY WAS PERFORMED ON 2018(PRECISE DATE IS UNKNOWN). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11505917 ↗
• InjuryDec 4, 2020Malposition of Device; Malposition of Device

  2 MONTHS AFTER PRIMARY SURGERY, THE PATIENT RETURNED FOR REVISION SURGERY DUE TO MALPOSITIONED CUP, DETECTED DURING ROUTINE SURGERY FOLLOW UP VISIT. AMIS REVISION APPROACH WAS UTILIZED, THE CUP WAS FOUND TO BE WELL FIXED BUT GROSSLY MALPOSITIONED. CUP HAS BEEN REVISED SUCCESSFULLY, MPACT REVISION CUP USED.

  Patient problems: Insufficient Information

  MAUDE report 10949659 ↗
• InjuryNov 6, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ASEPTIC CUP MOBILIZATION. THE SURGEON REVISED CUP, LINER AND HEAD 1 YEAR AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 10800548 ↗
• InjuryJul 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE SHELL MOVED (REASON UNKNOWN ) THE SURGEON DECIDED TO CHANGE CUP, LINER AND THE HEAD 4 MONTHS AND 4 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10223520 ↗
• InjuryFeb 14, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 9 MONTHS AFTER THE PRIMARY DUE TO THE IMPINGEMENT BETWEEN THE CUP AND THE STEM. THE CAUSE OF THE IMPINGEMENT IS UNKNOWN. THE CUP, LINER AND BALL HEAD WERE REVISED.

  Patient problems: Joint Disorder

  MAUDE report 9710885 ↗
• InjuryOct 3, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ALMOST 6 YEARS AND 7 MONTHS AFTER PRIMARY FOLLOWING CUP MOBILIZATION. HEAD, CUP AND LINER HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9150280 ↗
• InjurySep 26, 2018Appropriate Device Problem Term/Code Not Available

  INFORMATION RECEIVED ON 27 AUGUST 2018: PATIENT UNDERWENT PRIMARY SURGERY SUCCESSFULLY IN 2014. PATIENT RETURNED TO SURGEON THIS MONTH WITH PAIN, X-RAY SHOWED CUP HAD FLIPPED.

  Patient problems: Joint Disorder

  MAUDE report 7909557 ↗
• InjuryJun 21, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AFTER PRIMARY. THE SURGEON DETERMINED THAT THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGEON USED ANOTHER COMPANY'S CUP AND LINER WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7624921 ↗
• InjuryDec 6, 2017Fracture

  PATIENT RETURNED TO SURGEON FOR A CHECKED UP AND COMPLAINED OF PAIN. X-RAY REVEALED A ACETABULUM FRACTURE. SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2017.

  Patient problems: Bone Fracture(s)

  MAUDE report 7086821 ↗