Versafitcup CC TRIO Acetabular System 01.26.3648HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030807688), received between Mar 9, 2018 and Feb 12, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AT ABOUT 13 YEARS AND 8 MONTHS POST PRIMARY FOR STEM LOOSENING. THE LINER WAS FOUND WORN; IT IS UNKNOWN IF THE LINER WORN CONTRIBUTED TO THE STEM LOOSENING.

  Patient problems: Aseptic loosening

  MAUDE report 24321110 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  AT APPROXIMATELY 12 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, FEMORAL OSTEOLYSIS AND POSSIBLE LINER WEAR WERE DETECTED. REVISION SURGERY WAS PERFORMED IN WHICH THE HEAD AND LINER WERE REMOVED AND REPLACED WITH CERAMIC HEAD AND LINER, WHILE THE STEM AND CUP WERE NOT REVISED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20022567 ↗
• InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PE HC LINER WEAR, AT ABOUT FIVE YEARS FROM THE PRIMARY. THE PRIMARY SURGERY DATE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER AND THE COMPETITOR STEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19700408 ↗
• InjurySep 4, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION, 20 DAYS AFTER THE PREVIOUS REVISION SURGERY (PREVIOUSLY LINER AND HEAD WERE REVISED DUE TO DISLOCATION). THE INLAY WAS A MEDACTA PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 10493017 ↗
• InjuryAug 25, 2020Appropriate Device Problem Term/Code Not Available

  AMIS REVISION SURGERY PERFORMED AFTER 4 YEARS AND 9 MONTHS DUE TO PAIN. THE SURGEON REMOVED THE HEAD AND INLAY, AFTER THAT HE HIT THE STEM A FEW TIMES WITH AN PESTLE TO LOOK IF THE STEM IS LOOSENED. THE STEM WAS NOT LOOSENED. THE SURGEON IMPLANTED A NEW INLAY LINER F 32MM AND AN 32MM XXL COCR HEAD.

  Patient problems: Pain

  MAUDE report 10447984 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 7 YEARS AND 3 MONTHS FROM THE PRIMARY. THE SURGEON REVISED THE CUP, HEAD AND LINER AND REPLACE THEM WITH A DUAL MOBILITY CUP DUE TO DISLOCATION THE HEAD FROM THE LINER DUE TO THE PATIENT WEIGHT. THE STEM WAS NOT REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 9961668 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem

  REVISION OF ALL HIP COMPONENTS, 8 MONTHS AFTER PRIMARY SURGERY, DUE TO STREPTOCOCCOSIS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9568608 ↗
• InjuryMar 29, 2019Device Dislodged or Dislocated

  ABOUT 3 MONTHS AFTER PRIMARY REVISION THE SURGEON REVISED THE PATIENT FOR HIP DISLOCATION (HEAD FROM LINER) DUE TO A GLUTEAL REPAIR RUPTURE. REVISION HAS BEEN PERFORMED SUCCESSFULLY USING COMPETITOR CONSTRAINED CUP AND LINER AND MEDACTA HEAD. SURGEON COMMENTED THAT THERE WAS GREAT BONE IN GROWTH ON CUP AND NEEDED EXPLANT TO GET OUT.

  Patient problems: Joint Dislocation

  MAUDE report 8464662 ↗
• MalfunctionOct 11, 2018Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  DURING SURGERY THE SURGEON WENT TO USE AN IMPLANT THAT WAS PACKAGED IN A BOX LABELLED AS A 36/F LINER. WHEN THE SURGEON IMPLANTED THE LINER INTO A 56MM CC TRIO CUP, THE LINER SEEMED TO BE TOO SMALL. UPON FURTHER INVESTIGATION, THE AGENT AND SURGEON NOTICED THAT THE BOX AND STICKERS WERE LABELLED WITH 36/F YET THE IMPLANT AND IMPLANT BLISTER PACK WAS LABELLED 32/E LINER. THE AGENT USED A SECOND IMPLANT TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7955804 ↗
• InjurySep 26, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION AFTER ABOUT 1 MONTH FROM THE PRIMARY. THE PATHOGEN IS NOT KNOWN. HEAD AND INLAY WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 7909562 ↗
• InjuryMar 9, 2018Insufficient Device Problem Information

  ON (B)(6) 2018 MEDACTA HAS BEEN INFORMED BY THE SALES AGENT THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN AT THIS TIME. ON (B)(6) 2018 SURGEON REVISED THE PATIENT.

  Patient problems: Pain

  MAUDE report 7326632 ↗