Versafitcup CC TRIO Acetabular System 01.26.45.0056Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630030807794), received between Aug 3, 2017 and May 26, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS FROM PRIMARY THE PATIENT UNDERGONE REVISION SURGERY DUE TO INFECTION THAT HAS GROWN IN THE IMPLANT AREA. AREA OF INTEREST SHOWED PUS AND HIGH CELLULAR ACTIVITY. SURGEON SUSPECTS THAT AN INFECTION HAS MIGRATED TO THE IMPLANT AREA FROM SOMEWHERE ELSE. ALL IMPLANTS WERE REVISED AND ANTIBIOTIC SPACER WAS IMPLANTED; SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22084241 ↗
• InjuryNov 3, 2023Malposition of Device; Malposition of Device

  AT ONE MONTH FROM THE PRIMARY, REVISION SURGERY DUE TO MALPOSITIONED VERSAFITCUP CC TRIO CUP. THE SURGEON HAD NOTICED DURING A ROUTINE RADIOLOGICAL CHECK THAT THE ACETABULUM CUP HAD SHIFTED. THE PATIENT DID NOT COMPLAIN OF PAIN AND THERE WERE NO INFECTIOUS PROBLEMS.

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

  MAUDE report 18063714 ↗
• InjuryDec 14, 2021Patient-Device Incompatibility

  THE PRIMARY SURGERY TOOK PLACE IN 2020 (THE EXACT DATE IS UNKNOWN). REVISION SURGERY PERFORMED ON (B)(6) 2021 BECAUSE OF A LOW-GRADE INFECTION AND OSTEOPOROSIS. ALL IMPLANTS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 12998610 ↗
• InjuryNov 15, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY ABOUT 2 YEARS AND 10 MONTHS AFTER PRIMARY DUE TO HIP INFECTION. DURING REVISION IT WAS FOUND THAT THE STEM WAS LOOSE. ANTIBIOTIC SPACER IMPLANTED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12809542 ↗
• InjuryOct 16, 2020Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  PRIMARY SURGERY PERFORMED ON THE(B)(6) 2020. ON THE (B)(6) (4 MONTHS AFTER PRIMARY) A HIP REVISION SURGERY WAS PERFORMED ON THE LEFT SIDE FOLLOWING A CUP TILTING PROBLEM FOR UNKNOWN REASON. EXPLANTATION OF A VERSAFITCUP TRIO SIZE 56 WITH MOBILE PARTS IN CERAMIC. REIMPLANTATION OF A VERSAFITCUP SIZE 58 (+ SCREW) WITH MOBILE PARTS IN CERAMIC.

  Patient problems: Insufficient Information

  MAUDE report 10689828 ↗
• InjuryOct 16, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO LOOSE KNEE (INSTABILITY). THE SURGEON REVISED THE GMK SPHERE CR TIBIAL INSERT S4L 13MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S4L - 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT SAID THAT THE PATIENT DID NOT HAVE LOOSE IMPLANTS, IT WAS THE KNEE ITSELF THAT FELT LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10689826 ↗
• InjuryJul 17, 2020Fracture

  REVISION SURGERY 6 MONTHS POST PRIMARY SURGERY FOR ACETABULAR FRACTURE. DURING THE REVISION ALSO STEM CAME OUT, SO THE SURGEON DECIDED TO REVISE ALL JOINT COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 10288603 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT A MONTH AFTER PRIMARY THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED NEW COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9698516 ↗
• InjuryNov 26, 2019Positioning Problem; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 6 MONTHS AFTER THE PRIMARY DUE TO ABDUCTOR PAIN, WEAKNESS AT EXERCISE AND INCREASED LEG LENGTH CAUSED BY MALPOSITIONING OF THE CUP. THE SURGEON REVISED THE CUP, LINER AND BALL HEAD SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9374816 ↗
• InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, ONE YEAR AND TWO MONTHS AFTER PRIMARY SURGERY, DUE TO INFECTION WITH STAPHILOCCOCUS.

  Patient problems: Unspecified Infection

  MAUDE report 8319904 ↗
• InjuryAug 17, 2018Insufficient Device Problem Information

  REVISION SURGERY DUE TO INFECTION 2 MONTHS AFTER PRIMARY SURGERY. PATHOGEN NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7793266 ↗
• InjuryFeb 9, 2018Device Dislodged or Dislocated

  REVISION DUE TO DISLOCATION OF THE HEAD 4 MONTHS AFTER PRIMARY. WHILST THE SURGEON WAS IMPLANTING A NEW HOODED INLAY, THE CUP DISLOCATED AND THERE WAS A SMALL FRACTURE AT THE ACETABULUM, SO THE VERSAFITCUP WAS REMOVED. THE REASON OF DISLOCATION WAS THAT THE CUP HAD TOO MUCH ANTEVERSION.

  Patient problems: Hip Fracture; Joint Dislocation

  MAUDE report 7258657 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE

  Patient problems: Unspecified Infection

  MAUDE report 6763321 ↗