iTotal® Hip Replacement System HCC032000001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M572HCC0320000011), received between Oct 29, 2018 and May 4, 2020 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K162719); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE HIP DISLOCATION. REVISION SURGERY OCCURRED AND THE SURGEON REVISED THE PATIENT TO AN OFF-THE-SHELF CUP AND LINER.

  Patient problems: No Code Available

  MAUDE report 10022286 ↗
• InjuryFeb 24, 2020Fracture

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED THEIR ACETABULUM. THE SURGEON REVISED THE PATIENT TO CORRECT THE ISSUE AND IMPLANTED AN OFF-THE-SHELF CUP.

  Patient problems: Fall

  MAUDE report 9747147 ↗
• MalfunctionNov 15, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT THE THREADED TIP OF THE INSERTER BROKE INSIDE THE CUP AND WAS NOT NOTICED UNTIL THE CUP WAS FULLY SEATED. THE SURGEON ELECTED TO LEAVE THE BROKEN PORTION OF THE INSERTER INSIDE IN THE CUP AS IT WAS NOT ABLE TO BE REMOVED AND WAS NOT IMPINGING THE LINER OR ANY OTHER COMPONENTS. THE REST OF THE CASE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9329164 ↗
• InjuryJun 25, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS RECURRENT DISLOCATIONS. REPLACEMENT LINERS, SCREWS, AND FEMORAL HEADS HAVE BEEN ORDERED FOR REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731181 ↗
• InjuryJun 4, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S POSTERIOR COLUMN OF THE ACETABULUM WAS LIKELY FRACTURED DURING SURGERY CAUSING SHIFTING OF THE CUP. A REVISION SURGERY IS PLANNED TO REPLACE THE CUP AND LINER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8668526 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND SUBSEQUENTLY DISLOCATED A FEW TIMES. HEADS, LINERS, AND ALL SCREWS HAVE BEEN ORDERED FOR REVISION SURGERY.

  Patient problems: Fall

  MAUDE report 8596524 ↗
• MalfunctionMay 9, 2019Break

  IT WAS REPORTED THAT THE CONFORMIS CUP IMPACTOR THREADS BROKE OFF, LEAVING THE FEMALE THREADS INSIDE THE CUP. THE CONFORMIS 59MM CUP WAS REMOVED AND THE THREADS COULD NOT BE REMOVED FROM THE CUP. THE CUP WAS REPLACED WITH A 58MM SIGNATURE CUP. THERE WAS A LIGHT PRESS FIT ACHIEVED AND TWO SIGNATURE SCREWS WERE USED TO SECURE THE CUP FURTHER. ONE CUP INSERTER THREADS BROKE OFF DURING CUP IMPACTION AND THE SECOND CUP INSERTER APPEARS TO BE CROSS THREADED. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8596519 ↗
• InjuryJan 29, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP HAS POST OPERATIVELY DISLOCATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285499 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PLANNED TO A 54 CUP AND 36 HEAD (GROUP D LINER). HOWEVER, A GROUP E LINER WAS IN BOX 1. THE CASE WAS COMPLETED SUCCESSFULLY WITH A CORRECT LINER FROM BOX 2.

  Patient problems: No Code Available

  MAUDE report 8211994 ↗
• InjuryOct 29, 2018Nonstandard Device

  IT WAS REPORTED THAT ON THE FEMUR, THE SURGEON IDENTIFIED DURING TRIALING STAGE COULD NOT ACHIEVE ADEQUATE FIXATION; CONVERTED TO OFF THE SHELF DESIGN. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8014768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162719. One submission often covers many models, so check the product and lot details in each record.

• Z-0064-2020 · Aug 22, 2019 · Terminated
  iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
• Z-0063-2020 · Aug 22, 2019 · Terminated
  iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
• Z-1775-2019 · Mar 29, 2019 · Terminated
  Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
• Z-0731-2019 · Oct 16, 2018 · Terminated
  iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101