Versafitcup CC TRIO Acetabular System 01.26.45.0050Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030807763), received between May 24, 2018 and Sep 16, 2026 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  At 6 months from the primary, the patient came in presenting pain and instability due to a cup that shifted position following primary surgery and the cause is unknown. The surgeon revised the Medacta cup and liner to a competitor cup and liner, and revised the 36mm Biolox Head S to a 36mm BIOLOX Option Head with option sleeve M. The surgery was completed successfully.

  Patient problems: Aseptic loosening

  MAUDE report 50784461 ↗
• InjuryJun 26, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 WEEKS AFTER PRIMARY THE PATIENT UNDERWENT REVISION SURGERY DUE TO A LOOSE CUP. A BONE DEFECT WAS NOTICED ON THE POSTERIOR-SUPERIOR ASPECT OF THE ACETABULAR WALL WHILE SOME BONE GROWTH WAS PRESENT AROUND THE SHELL. SURGEON REAMED THE ACETABULUM AGAIN, PLACED A BONE GRAFT AND IMPLANTED A NEW VERSAFIT CUP OF THE SAME SIZE OF THE EXPLANTED ONE, WITH SCREW. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22337294 ↗
• InjuryJan 25, 2024Osseointegration Problem; Osseointegration Problem

  AT 10 YEARS AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18578386 ↗
• InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. ABOUT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18451682 ↗
• InjuryJul 28, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP THAT HAD MIGRATED SUPERIOR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17413459 ↗
• InjuryApr 19, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16769103 ↗
• InjuryMar 22, 2023Osseointegration Problem; Osseointegration Problem

  REVISION PERFORMED 9 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO CUP LOOSENING. IT HAS BEEN REPORTED THAT, DURING THE REVISION, SIGNS OF WEAR WERE DETECTED ON THE LINER. HEAD, LINER AND CUP REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 16591724 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 4 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S IMPLANTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16021054 ↗
• InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED 2 MONTHS AND A HALF AFTER THE PRIMARY SURGERY DUE TO INFECTION. CUP, LINER, HEAD, AND STEM REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 12874311 ↗
• InjuryNov 10, 2021Positioning Problem; Positioning Problem

  REVISION SURGERY FOR DUE TO IMPIGMENT IN ABDUCTION BETWEEN THE NECK OF THE STEM AND THE CUP. AT 3 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, CUP, HEAD, AND LINER WERE REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CUP WAS REVISED TO IMPROVE THE ACETABULAR COVERAGE AND HEAD WAS REVISED TO EXTEND THE LENGTH OF THE LEG.

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

  MAUDE report 12786507 ↗
• InjuryApr 13, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT RETURNED TO THE SURGEON DUE TO PAIN. INVESTIGATIONS SHOWED THAT THE CUP HAD MIGRATED. THE REVISION SURGEON EXPLAINED THAT HE BELIEVED THIS WAS DUE TO THE PATIENT ORIGINAL DIAGNOSIS OF AVASCULAR NECROSIS (AVN) AND DYSPLASIA. THE BONE WAS SOFT IN THE ACETABULUM AND THE PATIENT HAS A HIGH WEIGHT. 7 YEARS AND 11 MONTHS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE ACETABULAR COMPONENTS AND THE CERAMIC HEAD.

  Patient problems: Pain

  MAUDE report 11654412 ↗
• InjuryMar 5, 2021Device Dislodged or Dislocated

  THE PATIENT RETURNED WITH PAIN, IN PARTICULAR A FEELING OF IMPINGEMENT WHEN FLEXED SEATED STEM-CUP, WITH A FEELING LIKE IT MAY LEVER OUT DISLOCATE. THE PATIENT HAD NOT DISLOCATED THOUGH. THE SURGEON BELIEVES THE PAIN REASON IS DUE TO THE EXTENSIVE SPINAL FUSION, A SURGERY THAT WAS PERFORMED BY ANOTHER NEUROSURGEON POST THE PRIMARY HIP REPLACEMENT CAUSING AN EXTREMELY STIFF LUMBAR SPINE. 5 YEARS AFTER PRIMARY THE SURGEON REVISED THE ACETABULAR COMPONENT VIA AN ANTERIOR APPROACH, USING THE MPACT CUP AND DM CONVERTER, WITH A REVISION SLEEVE AND HEAD. THE SURGERY WAS TECHNICALLY SUCCESSFUL, WITH ADEQUATE LEG LENGTH AND OFFSET ACHIEVED.THE REMOVED COMPONENTS SHOWED SIGNIFICANT EDGE WEAR DUE TO FEMORAL STEM IMPINGEMENT WITH THE CUP, THE SURGEON BELIEVES AS A RESULT OF THE SPINAL SURGERY CAUSING CHANGES TO THE PELVIC ROTATION.

  Patient problems: Insufficient Information

  MAUDE report 11421485 ↗
• InjuryJul 22, 2020Appropriate Device Problem Term/Code Not Available

  IMPINGEMENT OF THE PSOAS. THE CUP WAS NOT WELL-POSITIONED. 3 YEARS AND 1 MONTH AFTER PRIMARY, REVISION SURGERY SUCCESSFULLY PERFORMED.

  Patient problems: Joint Disorder

  MAUDE report 10306842 ↗
• InjuryDec 23, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED, 3 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY, DUE TO CUP LOOSENING. ANTERIOR APPROACH USED DURING THE REVISION. ALSO THE HEAD, LINER AND THE SCREWS HAVE BEEN REMOVED. THE SURGEON SUSPECTS THE PATIENT HAD A CYST OR BONE DEFECT THAT COLLAPSED CAUSING THE IMPLANT TO MOVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9510715 ↗
• InjuryDec 5, 2019Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO INFECTION 3 YEARS AFTER THE PRIMARY SURGERY. ON THE (B)(6) 2017 THE PATIENT HAS BEEN REVISED (HEAD) DUE TO HIP DISLOCATION, CAUSED BY TRAUMA.

  Patient problems: Unspecified Infection

  MAUDE report 9416244 ↗
• InjurySep 3, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT PRESENTED WITH PAIN, AND LOOKING AT THEIR X-RAY IT CAN CLEARLY BEEN SEEN THAT THE CUP HAS ROLLED OVER. THE PATIENT REQUIRES REVISION SURGERY. THE REASON FOR REVISION IS ACETABULAR LOOSENING. THE SURGEON REVISED CUP, LINER AND HEAD 5 YEARS AND 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.WE WERE INFORMED ABOUT THE EVENT ON (B)(6). THE REVISION SURGERY WAS PERFORMED ON (B)(6).

  Patient problems: Joint Disorder

  MAUDE report 8955163 ↗
• MalfunctionJul 31, 2019Fitting Problem

  DURING THE HIP REPLACEMENT SURGERY, THE SURGEON DECIDED TO OPEN AND IMPLANT THE VERSAFIT CC TRIO CUP DIAM. 50 BECAUSE HE USED THE ACETABULAR REAMER DIAM. 50 AND THE TRIAL CUP DIAM. 50. HOWEVER, WHEN THE SURGEON WAS GOING TO IMPACT THE FINAL CUP, IT DID NOT FIX CORRECTLY IN THE ACETABULUM. THEREFORE, HE DECIDED TO USE THE ACETABULAR REAMERS DIAM. 52 AND 54 AND HE FINALLY IMPLANTED THE VERSAFIT CC TRIO CUP DIAM. 54.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8844857 ↗
• MalfunctionJul 30, 2019Fitting Problem

  DURING THE HIP REPLACEMENT SURGERY, THE SURGEON DECIDED TO OPEN AND IMPLANT THE VERSAFIT CC TRIO CUP DIAM. 50 BECAUSE HE USED THE ACETABULAR REAMER DIAM. 50 AND THE TRIAL CUP DIAM. 50. HOWEVER, WHEN THE SURGEON WAS GOING TO IMPACT THE FINAL CUP, IT DID NOT FIX CORRECTLY IN THE ACETABULUM. THEREFORE, HE DECIDED TO USE THE ACETABULAR REAMER DIAM. 52 AND HE FINALLY IMPLANTED THE FINAL CUP DIAM. 52.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8841027 ↗
• InjuryNov 22, 2018Loose or Intermittent Connection

  ABOUT 20 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR CUP LOOSENING. CUP REVISED THROUGH AMIS APPROACH, WITH AN MPACT CUP Ø54 + TWO SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8098809 ↗
• InjuryOct 4, 2018Patient-Device Incompatibility

  PRIMARY SURGERY IN (B)(6) 2014. THE PATIENT HAS BEEN IN DISCOMFORT SINCE THE PRIMARY, THE SURGEON HAS BEEN CONSERVATIVELY MANAGING HER DISCOMFORT OVER THAT TIME. A RECENT BONE SCAN SHOWED HOTS SPOT IN THE HIP AREA AND THE SURGEON DECIDED TO EXPLANT ALL THE IMPLANTS. SURGEON SAID THE IMPLANTS WERE ALL IN GOOD CONDITION, WELL FIXED AND NO APPARENT REASON FOR THE PATIENTS DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 7933743 ↗
• InjuryJul 11, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO CUP MOBILIZATION 4 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED CUP, BALL HEAD AND LINER.

  Patient problems: No Code Available

  MAUDE report 7677486 ↗
• InjuryMay 25, 2018Loose or Intermittent Connection; Unstable

  REVISION SURGERY PERFORMED DUE TO CUP LOOSENING AFTER 6 MONTHS FROM PRIMARY. CUP AND LINER WERE REPLACED WITH A ZIMMER DEVICES, HEAD WAS REPLACED WITH MEDACTA HEAD. IN (B)(6) 2018 THE PATIENT PRESENTED TO SURGEON WITH PAIN AND INSTABILITY, HE EXPLORED THE JOINT AND FOUND A MASS OF INFLAMMATION DISCOLOURED BY METAL PARTICLES. THE PROPOSED SURGERY IS FOR THE STEM TO REMAIN IN PLACE AND REVISE THE ACETABULAR COMPONENT.

  Patient problems: Inflammation; Pain

  MAUDE report 7544742 ↗
• InjuryMay 24, 2018Mechanical Problem

  THE SURGEON REVISED THE PATIENT ABOUT 10 DAYS AFTER PRIMARY FOR A CUP MOBILIZATION. HE BELIEVES THE MOBILIZATION DEPENDS FROM THE ACETABULUM PREPARATION PERFORMED DURING THE PRIMARY SURGERY. THE SURGEON REVISED SUCCESSFULLY THE PATIENT JOINT.

  Patient problems: Joint Disorder

  MAUDE report 7540700 ↗