Versafitcup CC TRIO Acetabular System 01.26.45.0052Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630030807770), received between Dec 15, 2017 and May 15, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Malposition of Device

  REVISION SURGERY DUE TO ACETABULAR CUP MALPOSITIONING AFTER ABOUT 1 MONTH FROM PRIMARY. THE ACETABULAR COMPONENTS AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH CEMENTED COMPONENTS AND A DUAL MOBILITY BEARING.

  Patient problems: Implant Pain

  MAUDE report 25185359 ↗
• InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY PERFORMED APPROXIMATELY 13 YEARS AND 5 MONTHS AFTER THE PRIMARY PROCEDURE DUE TO CUP LOOSENING SECONDARY TO GRANULOMA-INDUCED BONE RESORPTION. CUP, LINER AND HEAD SUCCESSFULLY REVISED.

  Patient problems: Aseptic loosening

  MAUDE report 23591899 ↗
• InjuryAug 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR AN IATROGENIC ACETABULUM BONE FRACTURE ABOUT 11 DAYS AFTER THE PRIMARY. ACCORDING TO THE SURGEON, POST-OP X-RAYS SUGGEST POSSIBLE OVERREAMING. THE FRACTURE IS ALSO ATTRIBUTED TO THE PATIENT'S POOR BONE QUALITY (A WOMAN OF 87 YEARS OLD). THE PATIENT HAD POOR BONE QUALITY. ALL COMPONENTS WERE REVISED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 22714428 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN AND THE CAUSE WAS UNKNOWN. UPON REVISING THE PATIENT, THE SURGEON NOTICED THAT THERE WAS VERY LITTLE POSTERIOR WALL COVERAGE ON THE ACETABULAR COMPONENT. AT ABOUT 12 YEARS AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER WITHOUT REVISING THE SHELL BECAUSE THE POSITION WAS NOT SO CRITIC TO JUSTIFY THE REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22269579 ↗
• MalfunctionDec 5, 2023Mechanical Problem; Mechanical Problem

  DURING SURGERY, THE HOODED PE HC FIXED LINER Ø 32 COULDN'T BE CLIPPED INTO THE CUP. THE SAME PROBLEM HAPPENED WITH ANOTHER HOODED PE HC FIXED LINER Ø 32 FROM A DIFFERENT LOT. THE SURGEON DECIDED TO REMOVE THE CUP AND IMPLANTED A NATIVE CEMENTED CUP TO COMPLETE THE SURGERY. DELAY TIME 30 MINUTES.

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

  MAUDE report 18266624 ↗
• InjuryMay 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 11 YEARS 2 MONTHS, REVISION SURGERY PERFORMED. THE PATIENT HAD OSTEOLYSIS AND THE CUP HAD LOOSENED AND MOVED. THERE WAS A SIGN OF THE HEAD IN THE POLY LINER, LIKE DEFORMATION/WEAR OF THE LINER PERFORMED BY THE CONTACT WITH THE METAL HEAD. THE SURGEON REVISED SUCCESSFULLY CUP, LINER AND HEAD. STEM WAS ALSO REMOVED.

  Patient problems: Osteolysis

  MAUDE report 16963026 ↗
• InjuryMay 6, 2022Failure to Osseointegrate

  REVISION SURGERY PERFORMED 1 YEAR AND 1 MONTH AFTER THE PRIMARY FOLLOWING NO OSSEOINTEGRATION OF THE CUP. THE SURGEON REVISED THE MEDACTA CUP WITH A COMPETITOR CUP AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14300054 ↗
• InjuryNov 4, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AT 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE ACETABULAR AND FEMORAL COMPONENTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12751296 ↗
• InjuryJun 18, 2021Appropriate Device Problem Term/Code Not Available

  HIP REVISION SURGERY PERFORMED ON THE RIGHT SIDE FOLLOWING ANTERIOR PAIN ONLY, NO INFECTION OR IMPLANT LOOSENING. CUP, LINER AND HEAD HAVE BEEN SUCCESSFULLY REVISED 1 YEAR AND 11 MONTHS AFTER PRIMARY.

  Patient problems: Pain

  MAUDE report 12023462 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN AND DURING THE REVISION SURGERY, WHICH WAS PERFORMED 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, STEM NECK-CUP IMPINGEMENT AND METALLOSIS WERE NOTICED. THE SURGEON BELIEVES THAT A COMBINATION OF THE PATIENT LUMBAR LORDOTIC ANGLE AND THE FIRST REVISION SURGERY((B)(6) 2020 THIS PATIENT HAD A STEM AND HEAD REVISION DUE TO STEM MOBILIZATION) TO A MINIMAX STEM WITH INBUILT ANTEVERSION, MAY HAVE RESULTED IN THE POSTERIOR IMPINGEMENT (BETWEEN THE CUP AND THE NECK OF THE STEM), AND SUBSEQUENT REQUIREMENT FOR LESS ANTEVERSION ON THE CUP. THE SURGEON REVISED THE CUP, LINER AND HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 11633015 ↗
• InjuryJun 12, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 3 MONTHS AFTER PRIMARY SURGERY FOR CUP MOBILIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY, CUP, LINER AND CERAMIC HEAD SWAPPED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10148612 ↗
• InjuryDec 27, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO SUSPICION OF INFECTION 5 YEARS 5 MONTHS AND A HALF AFTER PRIMARY. THE IMPLANTS WERE LOOSE, ESPECIALLY THE STEM.

  Patient problems: Unspecified Infection

  MAUDE report 9523300 ↗
• InjuryNov 5, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED 2 SCREWS, HEAD, LINER AND CUP ALMOST 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9278375 ↗
• InjuryJun 27, 2019Mechanical Problem; Inadequacy of Device Shape and/or Size; Positioning Problem

  REVISION SURGERY AFTER 1 YEAR AND 1 MONTH FROM THE PRIMARY DUE TO PAIN CAUSED BY MECHANICAL CONFLICT WITH THE PSOAS. THE CUP HAS BEEN REVISED. THE CUP WAS PROBABLY IN BAD POSITION AND OVERSIZED.

  Patient problems: Pain

  MAUDE report 8739735 ↗
• InjuryJun 13, 2019Malposition of Device; Malposition of Device

  ABOUT 1 YEAR AFTER PRIMARY SURGERY THE SURGEON REVISED THE MEDACTA TOTAL HIP DUE TO ACETABULUM IMPLANT MALPOSITION, APPROXIMATIVELY 50° ANTEVERTED, WHICH CAUSED CUP AND STEM TO RUB ON EACH OTHER AND STEM HAD WORKED LOOSE. ALL IMPLANTS REVISED SUCCESSFULLY AND COMPETITOR IMPLANTS IMPLANTED. PRIMARY SURGERY PERFORMED WITH AMIS TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8695353 ↗
• InjuryAug 17, 2018Loose or Intermittent Connection

  REVISION DUE TO INFECTION 9 MONTHS AFTER PRIMARY: ABSCESS FOUND. THE PATIENT STARTED COMPLAINING ABOUT PAIN IN (B)(6) 2018, AFTER AN URINARY INFECTION. AT THE LAB THERE WAS NO EVIDENCE OF ANY GERM. DURING REVISION THE STEM WAS NOT LOOSE BUT THE CUP WAS LOOSE AND IT WAS EASILY REMOVED: ALL THE IMPLANTS HAVE BEEN REMOVED AND AN CEMENT SPACER WITH ANTIBIOTICS HAS BEEN IMPLANTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7793275 ↗
• InjuryApr 6, 2018Appropriate Device Problem Term/Code Not Available

  ON 08 MARCH 2018 MEDACTA'S SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY WILL BE NECESSARY DUE TO IMPLANT DISLOCATION. ADDITIONAL INFORMATION RECEIVED ON 21ST MARCH 2018 BY SALES REPRESENTATIVE: THE CUP INLAY AND HEAD HAVE BEEN REMOVED. THE EXPLANTED IMPLANTS ARE NOT AVAILABLE. IT WAS NOT AN IMPLANT FAILURE BUT WRONG POSITIONING OF THE CUP ( TOO MUCH ANTEVERSION AND INCLINATION). THE REVISION WAS DUE TO BAD CUP POSITION IN PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 7402536 ↗
• InjuryFeb 22, 2018Device Slipped

  REVISION DUE TO PROXIMAL ASEPTIC LOOSENING OF A QUADRA-C CEMENTED STEM 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE INVOLVED STEM WAS IMPLANTED IN (B)(6) 2016 DURING A REVISION SURGERY PERFORMED DUE TO ASEPTIC LOOSENING IN THE PROXIMAL PART OF A CEMENTED COMPETITOR STEM. THE SURGEON REMARKED THAT IT CAN BE DUE TO THE CEMENT BUT IT IS NOT INVESTIGABLE.

  Patient problems: Joint Disorder

  MAUDE report 7288220 ↗
• InjuryDec 15, 2017Fracture

  REVISION SURGERY PERFORMED, DUE TO ACETABULAR WALL FRACTURE, 6 DAYS AFTER PRIMARY SURGERY. THE FRACTURE OF THE ACETABULAR WALL OCCURRED DURING THE PRIMARY. THE SURGEON REVISED THE CUP, HEAD LINER AND SCREWS.

  Patient problems: Bone Fracture(s)

  MAUDE report 7121398 ↗