Versafitcup CC TRIO Acetabular System 01.26.45.0048Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07630030807756), received between May 24, 2018 and Jul 10, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Malposition of Device

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2026. ON (B)(6) 2026, REVISION SURGERY WAS PERFORMED ON THE LEFT SIDE. ACCORDING TO THE SURGEON, THE REVISION WAS REQUIRED DUE TO INCORRECT POSITIONING OF THE ACETABULAR IMPLANT DURING THE PRIMARY SURGERY, WITH SUBSEQUENT IMPLANT LOOSENING. NO LOOSENING OF THE FEMORAL STEM AND NO INFECTION WERE REPORTED. ALL COMPONENTS WERE EXPLANTED, EXCEPT FOR THE MINIMAX STEM. REIMPLANTATION WAS PERFORMED USING A REINFORCEMENT CAGE, AN APRICOT 44, AND A CRCO BALL HEAD 32 M.

  Patient problems: Implant Pain

  MAUDE report 25778111 ↗
• InjuryJul 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO A LOOSE CUP AFTER ABOUT 5 YEARS AND 3 MONTHS. THE SURGEON REVISED THE VERSAFITCUP METALBACK CC TRIO D 48 MM TO A MPACT 3D METAL SHELL TWO HOLE D 52MM, REVISED THE FLAT PE HC LINER D 32/C TO A DOUBLE MOBILITY HC LINER D 28/DMC WITH DM CONVERTER, AND REVISED THE 32MM BIOLOX DELTA HEAD M TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25763494 ↗
• InjuryFeb 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO ACETABULAR BONE PERFORATION, AT ABOUT 4 DAYS AFTER PRIMARY. ALL COMPONENTS WERE REVISED. THE SURGEON REPORTS THAT THE EVENT THAT CAUSED THE PERFORATION WAS DUE TO THE PATIENT'S FAILURE TO LOAD POST-OPERATIVELY. THE PATIENT HERSELF OVERLOADED FROM THE DAY AFTER SURGERY. NO INTRAOPERATIVE PROBLEMS WITH REAMING AND IMPACTION.

  Patient problems: Bone Fracture(s)

  MAUDE report 21375044 ↗
• InjuryDec 21, 2023Malposition of Device; Malposition of Device

  AT ABOUT 2 YEARS 2 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED ON THE LEFT SIDE DUE TO MEDIALIZATION OF THE ACETABULAR CUP AND SUBOPTIMAL OFFSET. PATIENT HAD DISCOMFORT SINCE THE PRIMARY SURGERY. NO LOOSENING OF THE IMPLANTS. NO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE CUP, LINER AND HEAD.

  Patient problems: Discomfort

  MAUDE report 18372060 ↗
• InjuryApr 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ALL RIGHT HIP COMPONENTS REVISED ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, DUE TO LOOSENING OF THE FEMORAL STEM, LIKELY CAUSED BY AN INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 16761590 ↗
• InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION 10 MONTHS AFTER THE PRIMARY SURGERY. ALL IMPLANTS REMOVED AND REVISED WITH COMPETITOR IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 13505691 ↗
• InjuryDec 13, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY DUE TO INFECTION. THE SURGEON REMOVED ALL IMPLANTS AND WASHED THE AREA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12982794 ↗
• InjurySep 15, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2021. THE PATIENT HAD FIRST REVISION SURGERY DUE TO BONE FRACTURE ON (B)(6) 2021. THE FRACTURE WAS CAUSED BY PATIENT'S FALL. ONLY AMISTEM-P STEM AND COCR HEAD WERE REVISED. M-VIZION STEM AND NEW COCR HEAD IMPLANTED. ON (B)(6) 2021 LUXATION OCCURRED DUE TO TOO MUCH ANTEVERSION OF THE CUP. CUP, HEAD, AND LINER WERE REVISED.

  Patient problems: Bone Fracture(s); Fall; Subluxation

  MAUDE report 12474791 ↗
• InjuryMay 19, 2021Malposition of Device; Malposition of Device

  REVISION SURGERY PERFORMED DUE TO DISLOCATION (HEAD FROM THE LINER) DUE TO MALPOSITION OF THE CUP (EXTREME ANTEVERSION OF MORE THAN 60 DEGREES). THE ACETABULAR HARDWARE WAS REVISED THROUGH THE AMIS APPROACH 10 DAYS AFTER THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 11847273 ↗
• InjuryNov 3, 2020Osseointegration Problem; Osseointegration Problem

  TILTING OF THE ACETABULAR CUP NOTED 3 MONTHS AFTER THE PRIMARY OPERATION BY A CONTROL X-RAY. THE SURGEON OFFERED THE PATIENT ANOTHER OPERATION TO REPOSITION THE CUP IN FEBRUARY, BUT THE PATIENT REFUSED BECAUSE SHE HAD NO PAIN. THE PAIN STARTED 2 MONTHS AGO AND SHE FINALLY ACCEPTED THE REVISION SURGERY. CUP, LINER AND HEAD HAVE BEEN SUCCESSFULLY REVISED 1 YEAR AFTER PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 10776898 ↗
• InjuryOct 28, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 2 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN. THE SURGEON REVISED SUCCESSFULLY THE PATIENT SHELL AND LINER.

  Patient problems: Pain

  MAUDE report 10746163 ↗
• InjuryJul 8, 2020Appropriate Device Problem Term/Code Not Available

  THE SURGEON INFORMED ME THAT THE PATIENT WAS A VERY FLEXIBLE, PREVIOUSLY DYSPLASTIC ANATOMY WHO EXPERIENCED ONGOING PAIN AND LIMPING. THE ACETABULAR COMPONENT MAY HAVE BEEN CAUSING PSOAS IRRITATION. THE SURGEON EXPLANTED THE CUP (2 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY) AND CONTINUED TO REAM THE ACETABULUM DEEPER, REPLACING WITH A G7 DUAL MOBILITY CUP WITH ACETABULAR SCREWS. ALSO THE HEAD HAS BEEN REVISED.

  Patient problems: Pain

  MAUDE report 10243563 ↗
• InjuryNov 20, 2019Fracture

  ACETABULAR WALL BONE FRACTURE DURING CUP POSITIONING. A CEMENTED CUP WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9346912 ↗
• InjuryJul 24, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY DUE TO RADIOLUCENCIES (STEM + ACETABULUM) AND STEM LOOSENING. THE CUP, LINER, BALL HEAD AND STEM HAVE BEEN REVISED.

  Patient problems: Joint Disorder

  MAUDE report 8821370 ↗
• InjuryMay 2, 2019Device Dislodged or Dislocated

  ON APRIL 2ND WE WERE INFORMED ABOUT A REVISION PERFORMED ON APRIL 23RD, 2 MONTHS FROM THE PRIMARY DUE TO HIP DISLOCATION (HEAD FROM LINER). THE CUP WAS NOT SEATED SUFFICIENTLY, ANTEVERTED TO 45 DEGREES AND ACETABULAR APPEARING UNDER-REAMED. REVISION SURGERY HAS BEEN PERFORMED WITH POST/LATERAL APPROACH, NO INFECTION HAS BEEN DETECTED AND THE PATIENT WAS ELECTED TO LEAVE THE STEM AND THE HEAD IN SITU. POLY, CUP AND ONE SCREW WERE REMOVED. REVISION SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8573531 ↗
• InjuryApr 12, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO CUP MOBILIZATION, 2 YEARS AND 4 MONTHS AFTER PRIMARY. THE CUP HAS BEEN REPLACED WITH DOUBLE MOBILITY SYSTEM, INLAY AND HEAD HAVE BEEN REPLACED AS WELL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8508149 ↗
• InjuryOct 5, 2018Protective Measures Problem

  ABOUT 3 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR CUP IMPINGEMENT WITH PSOAS MUSCLE. CUP, LINER AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 7938084 ↗
• InjuryJul 20, 2018Loose or Intermittent Connection

  REVISION DUE TO ASEPTIC LOOSENING OF VERSAFITCUP CC TRIO 1 YEAR AND 7 MONTHS AFTER PRIMARY (AMIS APPROACH USED IN PRIMARY). THE SURGEON REPLACED CUP, LINER AND HEAD SUCCESSFULLY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7706399 ↗
• InjuryJun 6, 2018Positioning Problem

  THE PATIENT CAME IN DUE TO FEELING UNSTABLE 10 MONTHS AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THE CUP WAS TOO ANTEVERTED. THE SURGEON REVISED THE CUP, LINER AND SCREW. THE SURGEON REAMED TO A 52MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7572696 ↗
• InjuryMay 24, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN 5 DAYS AFTER THE PRIMARY. THE PATIENT HAD FRACTURED THE PELVIC WALL. THE CAUSE OF THE FRACTURE IS UNKNOWN, NO REPORT OF TRAUMA. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7540708 ↗
• MalfunctionMay 24, 2018Break

  THE CUP LOOSENED FROM THE TERMINAL DURING THE IMPLANT REPOSITIONING. THE SURGEON NOTICED THAT THE CUP THREAD WAS DAMAGED. A NEW CUP WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540703 ↗