Versafitcup CC TRIO Acetabular System 01.26.3239HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030807541), received between Jul 7, 2017 and Feb 24, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Device Dislodged or Dislocated

  AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. NO TRAUMA IS REPORTED. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24429829 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM THE PRIMARY, REVISION SURGERY DUE TO JOINT LUXATION BETWEEN LINER AND HEAD. LINER, HEAD AND CUP REVISED AND MPACT DM SUCCESSFULLY IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 19749504 ↗
• InjuryJan 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT WAS OCCURRED WHEN EXERCISING. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18516286 ↗
• InjuryDec 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 18266626 ↗
• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY PERFORMED ON (B)(6) 2023. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2023 DUE TO JOINT LUXATION (MEDACTA NOT INFORMED BECAUSE THE SURGEON WAS NOT A MEDACTA CLIENT); ONLY HEAD REVISED WITH A ZIMMER XL HEAD. ON (B)(6) 2023, THE JOINT LUXATED AGAIN AND HEAD LINER AND CUP WERE REVISED WITH A DOUBLE MOBILITY SYSTEM.

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

  MAUDE report 17170549 ↗
• InjuryJun 9, 2022Appropriate Device Problem Term/Code Not Available

  THE HEAD AND THE LINER WERE REVISED 19 DAYS AFTER PRIMARY DUE TO A SUPERFICIAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14641193 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER 3 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13515072 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 4 MONTHS AND A HALF AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12364717 ↗
• InjuryApr 14, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PLANNED FOR HIP INFECTION. NO FURTHER INFORMATION IS AVAILABLE AT 14 APRIL 2021. A LINER AND HEAD SUBSTITUTION HAVE BEEN REQUESTED BY THE HOSPITAL FOR THIS REVISION. IT IS UNKNOWN IF THE HEAD TO BE REVISED IS MEDACTA PRODUCT OR NOT.

  Patient problems: Unspecified Infection

  MAUDE report 11664354 ↗
• InjuryMay 19, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT CAME IN REPORTING PAIN, WHICH WAS CAUSED BY A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE 32MM BIOLOX S HEAD WITH A 32MM BIOLOX M HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, 11 MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10069359 ↗
• MalfunctionMay 10, 2019Difficult to Insert; Difficult to Insert

  THE INLAY DID NOT FIT INTO THE CUP. THE SURGEON TRIED A FEW TIMES TO IMPACT IT BUT IT WAS NOT POSSIBLE. THEN HE DECIDED TO USE A NEW INLAY OF THE SAME SIZE, WHICH FITTED INTO THE CUP.

  Patient problems: No Information

  MAUDE report 8599634 ↗
• InjuryOct 31, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 MONTH AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT HAD DISLOCATED HER HIP (HEAD DISLOCATED FROM LINER). THE PATIENT SAID THAT SHE DID NOT FALL OR EXPERIENCE ANY TRAUMA. THE SURGEON REVISED THE 32M HEAD TO A 32L. THE LINER WAS NOT REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8023980 ↗
• InjurySep 26, 2018Difficult to Insert

  DURING THE LINER IMPLANTATION THE SURGEON COULDN'T COMPLETELY INSERT THE INLAY INTO THE CUP. BEFORE IMPACTION HE CHECKED THAT THE CUP WAS CLEAN AND FREE FROM ANY POSSIBLE "DISTURBING" ITEMS (LIQUIDS, PARTICLES, TISSUES), ANYWAY HE COULDN'T INSERT THE LINER. THE LINER WAS THEN REMOVED WITH A SCREW AND HE INSERTED ANOTHER LINER C, HEAD 28. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909555 ↗
• InjuryJul 31, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE PATIENT HAD DISLOCATED. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7734730 ↗
• InjuryMay 25, 2018Particulates

  REVISION OF BALL HEAD AND LINER 2 YEARS AFTER PRIMARY DUE TO PSOAS IMPINGEMENT. INTRAOPERATIVE CLINICAL STATUS LOOKS LIKE INFECTED, HISTOLOGY MACROPHAGE INFILTRATION, BUT THE PATHOLOGY RESULTS CAME BACK NEGATIVE (NO INFECTION). SURGEON COMMENTED THAT HE FOUND DEBRIS FROM THE INLAY DURING THE REVISION.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7544740 ↗
• MalfunctionApr 27, 2018Device Contamination with Chemical or Other Material

  WHEN THE NURSE OPENED THE LINER BOX, SHE NOTICED A BLACK DOT ON THE IMPLANT. THE SURGEON DECIDED TO USE A BACK-UP LINER.

  Patient problems: No Patient Involvement

  MAUDE report 7468344 ↗
• MalfunctionJul 13, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE SURGEON AND THE SUPPORTING NURSE DETECTED THAT A SMALL POLYETHYLENE SLIVER IS STANDING AWAY FROM THE INLY AFTER OPENING THE WRAPPING. THE SURGEON DECIDED NOT TO IMPLANT THIS INLAY. HE USED A NEW INLAY OF THE SAME REFERENCE AND IMPLANTED IT WITHOUT ANY PROBLEMS.

  Patient problems: No Patient Involvement

  MAUDE report 6710269 ↗
• InjuryJul 7, 2017Unstable; Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE PATIENT DISLOCATED ANTERIORLY. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 6692864 ↗