Versafitcup CC TRIO Acetabular System 01.26.45.0054Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030807787), received between Nov 10, 2017 and May 22, 2026 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP REPLACEMENT ON (B)(6) 2024. APPROXIMATELY 8 MONTHS AGO, THE PATIENT REPORTED PAIN IN THE RIGHT HIP AREA. INVESTIGATIONS CONFIRMED A PROSTHETIC JOINT INFECTION. ON THE (B)(6) 2026, THE IMPLANTS WERE EXPLANTED, AND A TEMPORARY STEM AND CUP WERE IMPLANTED, WITH PLANNED REVISION SURGERY ONCE THE INFECTION IS RESOLVED. THE ORIGIN OF THE INFECTION IS NOT KNOWN. THE PATIENT HAS MULTIPLE RISK FACTORS (COMORBIDITIES SUCH AS DIABETES AND MORBID OBESITY) THAT MAKE FINDING THE ORIGIN OF THE INFECTION DIFFICULT. THE STEM AND CUP WERE WELL FIXATED, MAKING IMPLANT REMOVAL PROLONGED AND TECHNICALLY DEMANDING.

  Patient problems: Medical device site infection

  MAUDE report 25253489 ↗
• InjuryOct 31, 2024Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR SUSPECTED INFECTION. THE SURGEON REMOVED ALL IMPLANTS, (THE STEM AND HEAD WERE FROM COMPETITOR). THE SURGEON IMPLANTED COMPETITOR DEVICES. PATIENT HISTORY: PRIMARY SURGERY ON (B)(6) 2020. FIRST REVISION ON (B)(6) 2024 FOR STEM LOOSENING (STEM AND HEAD OF COMPETITOR IMPLANTED). SECOND REVSION ON (B)(6) 2024 FOR SUSPECTED INFECTION AND LOOSENING OF COMPETITOR STEM.

  Patient problems: Medical device site infection

  MAUDE report 20578477 ↗
• InjuryDec 22, 2023Malposition of Device; Malposition of Device

  REVISION SURGERY DUE TO OVERHANG VERSAFITCUP CC TRIO CUP. CUP, HEAD AND LINER SUCCESSFULLY REVISED. PRIMARY INFO NOT AVAILABLE.

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

  MAUDE report 18382170 ↗
• InjuryOct 6, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 6 YEARS AND 6 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO ACETABULAR LOOSENING FOLLOWING UNEXPLAINED BONE LOSS IN THE POSTERIOR PART OF THE ACETABULUM. NO INFECTION. ALL DEVICES REVISED. THE SURGEON DECIDED TO REMOVE ALSO THE STEM FOR PLACEMENT OF COMPETITION REVISION IMPLANTS.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17885038 ↗
• InjuryDec 15, 2022Malposition of Device; Malposition of Device

  AT ABOUT 9 YEARS 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSTIONED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 15987326 ↗
• InjuryApr 22, 2022Appropriate Device Problem Term/Code Not Available

  PRIMARY DATE ON (B)(6) 2019. FIRST REVISION SURGERY ON (B)(6) 2019 AND (B)(6) 2019 DUE TO INFECTION (ENTEROCOCCUS FAECALIS E ACINETOBACTER), DEEP WOUND CLEANSING AND CHANGE OF HEAD AND LINER. PRESENTLY, (B)(6) 2022, THE PATIENT WAS REVISED DUE TO INFECTION (ENTEROCOCCUS FECALIS). ALL IMPLANTS REMOVED AND SPACER IMPLANTED. REF AND LOT ARE NOT AVAILABLE AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 14186627 ↗
• InjuryJul 8, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 11 DAYS AFTER THE PRIMARY DUE TO HIP LUXATION CAUSED BY MOBILIZED CUP. THE SURGEON REVISED THE CUP, INLAY AND HEAD.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 12133519 ↗
• InjuryDec 1, 2020Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 WEEKS AFTER PRIMARY SURGERY DUE TO CUP MIGRATION. THE PATIENT HAS DDH (DEVELOPMENTAL DYSPLASIA OF THE HIP). THE REVISION WAS PERFORMED SUCCESSFULLY, ONLY ACETABULAR COMPONENTS SWAPPED WITH COMPETITOR DEVICES. THE STEM WAS WELL FIXED.

  Patient problems: Insufficient Information

  MAUDE report 10928261 ↗
• InjuryApr 2, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 6 YEARS AFTER PRIMARY SURGERY, DUE TO INFECTION. ALL THE IMPLANTS HAVE BEEN SUCCESSFULLY REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9914996 ↗
• InjuryAug 22, 2019Inadequacy of Device Shape and/or Size

  THE SURGEON BELIEVED THAT THE PRIMARY CUP WAS OVERSIZED AND TOO INCLINED. IN FACT THE PATIENT FELT PAIN AND HAD ABNORMAL ANATOMY/GAIT. CUP, LINER AND BALL HEAD WERE REVISED 3 YEARS AND 4 MONTH AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8919937 ↗
• MalfunctionMay 15, 2019Device Damaged by Another Device; Device Damaged by Another Device

  WHEN THE SURGEON INTRODUCED THE CUP INTO THE ACETABULUM THE THREAD OF THE TERMINAL CUP IMPACTOR BROKE OUT OF THE CUP AND DAMAGED THE THREAD OF THE CUP. A NEW CUP WITH THE STRAIGHT IMPACTOR WAS USED TO COMPLETE SUCCESSFULLY THE SURGERY. THE THREAD BREAKS OUT WHEN HE WAS PUSHING THE CUP DOWN TO GET THE RIGHT ANTEVERSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612053 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PLANNED FOR (B)(6) 2019 DUE TO PAIN, 3 YEARS AND A HALF AFTER THE PRIMARY SURGERY. THE SURGEON IS PLANNING TO REMOVE THE VERSAFIT CUP, LINER AND SCREWS AND WILL REVISE THE STEM IF REQUIRED.

  Patient problems: Pain

  MAUDE report 8217186 ↗
• InjuryOct 19, 2018Device-Device Incompatibility

  ON SEPTEMBER 20, 2018 WE WERE INFORMED THAT FIVE YEARS AFTER THE PRIMARY, THE PATIENT UNDERWENT TO ADDITIONAL SURGERY DUE TO PSOAS PAIN ESCALATING IN THE PAST YEAR AND A SOFT TISSUE RELEASE WAS PERFORMED. ANTERIOR CUP IMPINGEMENT WAS NOTICED AT THAT TIME. THE PATIENT HAS NOW PRESENTED A DISLOCATION (5 YEARS ANS 3 MONTHS AFTER PRIMARY SURGERY). THE SURGEON FEELS THAT THE CUP WAS TOO BIG, SAT OUT OF THE ACETABULUM AND THE CUP VERSION WAS INCORRECT WHICH WOULD HAVE BEEN THE SOURCE OF SOFT TISSUE IRRITANT. ON (B)(6) 2018 THE CUP WAS REPLACED WITH A G7 DM CUP. THE STEM REMAINED AND ONLY A HEAD CHANGE WAS REQUIRED FROM MEDACTA.

  Patient problems: Joint Dislocation

  MAUDE report 7984665 ↗
• InjuryJun 1, 2018Device Slipped

  REVISION SURGERY DUE TO ACETABULAR SHELL LOOSENING 3 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE CUP, LINER AND FEMORAL HEAD.

  Patient problems: Joint Disorder

  MAUDE report 7560666 ↗
• InjuryApr 25, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 WEEK AFTER PRIMARY DUE TO CUP MOBILIZATION, DETECTED 2 DAYS AFTER IMPLANTATION. THE CUP WAS REMOVED AND AN MPACT TWO-HOLES TG 52 WAS IMPLANTED, FIXED WITH TWO SCREWS. THE BALL HEAD AND THE LINER WERE REVISED, TOO. POSTERO-LATERAL APPROACH USED IN PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 7458225 ↗
• MalfunctionApr 19, 2018Disconnection

  THE TERMINAL CUP IMPACTOR DISCONNECTED FROM THE CUP WHEN THE SURGEON WAS POSITIONING THE CUP. THEY TRIED AGAIN BUT IT DISCONNECTED AGAIN. THEN THEY USED A NEW CUP WITH THE SAME CUP IMPACTOR. THE TERMINAL CUP IMPACTORS IN THE HOSPITAL SHOW NO DAMAGE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442498 ↗
• InjuryApr 13, 2018Device Slipped

  REVISION SURGERY PERFORMED TO REMOVE CUP AS IT WAS LOOSE AND HAD MOVED ABOUT SEVEN YEARS FROM THE PRIMARY. SURGEON SUSPECTED A LOOSE CUP DUE TO ITS POSITION AND SYMPTOMS FROM PATIENT. HE ALSO SUSPECTED INFECTION AND SENT OF TISSUE SAMPLES TO CONFIRM.

  Patient problems: Joint Disorder

  MAUDE report 7428044 ↗
• MalfunctionApr 12, 2018Device Issue; Device Issue

  DURING FINAL IMPLANT IMPACTION, THE CUP ADAPTOR BECAME LOOSE FROM THE IMPLANT AND THEREFORE WAS NOT ABLE TO BE USED. THE SURGEON TRIED WITH THE REF 01.26.10.0162 LONG STRAIGHT MULTIFUNCTION HANDLE, BUT THESE ALSO BECAME LOOSE FROM THE CUP. HE BELIEVED THAT THE IMPLANT THREAD WAS DAMAGED AND THEREFORE INSTRUMENT THREAD WOULD NO LONGER HOLD IT. THEN, HE REMOVED THE CUP WITH THE STRAIGHT CUP IMPACTOR (REF 01.26.10.0062) AND IT REMAINED STUCK WITH THE IMPLANT. HE TOOK ANOTHER CUP (SAME REF, BUT LOT 175392) THAT WAS SUCCESSFULLY IMPLANTED WITH THE FIRST OFFSET HANDLE (COUPLED WITH REF 01.15.10.0261) USED BY THE SURGEON. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7425009 ↗
• InjuryDec 29, 2017Migration or Expulsion of Device; Device Dislodged or Dislocated

  THE SAME DAY OF PRIMARY SURGERY THE PATIENT LUXATED HIS HIP FOR AN INVOLUNTARY CONTRACTION. AFTER A FIRST ANATOMICAL REDUCTION THE PATIENT HIP RE-LUXATED AND THIS TIME A CUP MIGRATION WAS DETECTED. THE SURGEON REVISED THE PATIENT THE SAME DAY SWAPPING SUCCESSFULLY THE CUP IMPLANTS AND THE STEM HEAD.

  Patient problems: Joint Disorder

  MAUDE report 7153831 ↗
• InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A DEEP JOINT INFECTION DUE TO WHICH A REVISION SURGERY PERFORMED. PATHOGEN IS NOT AVAILABLE. ACCORDING TO THE SURGEON THE REVISION SURGERY HAS BEEN THE BEST OPTION POSSIBLE.

  Patient problems: Unspecified Infection

  MAUDE report 7018019 ↗