iTotal® Hip Replacement System HAA050D00101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M572HAA050D001011), received between Nov 19, 2018 and Apr 30, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2019Difficult to Remove; Positioning Problem

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY REMOVING THE TRIAL LINER AFTER IMPLANTING THE FINAL STEM. THE SURGEON WAS UNABLE TO PLACE THE PLANNED LINER WITH THE STEM IN PLACE. THE SURGEON HAD TO REMOVE THE STEM TWICE TO PLACE THE PLANNED LINER. THE SURGEON SCUFFED THE NECK OF THE STEM WHILE REMOVING IT DUE TO THE LACK OF A STEM REMOVAL TOOL. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8566402 ↗
• InjuryNov 21, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A POPPING WITH THEIR HIP REPLACEMENT.

  Patient problems: No Code Available

  MAUDE report 8094440 ↗
• MalfunctionNov 19, 2018Application Program Problem

  IT WAS DISCOVERED THAT THE IVIEW FOR THE 32XL FEMORAL HEAD WHERE THE LEG LENGTH AND FEMORAL OFFSETS WERE MISCALCULATED. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085808 ↗
• MalfunctionNov 19, 2018Inadequacy of Device Shape and/or Size

  IT WAS DISCOVERED THAT THE IVIEW FOR THE 32XL FEMORAL HEAD WHERE THE LEG LENGTH AND FEMORAL OFFSETS WERE MISCALCULATED. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085807 ↗

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-0063-2020 · Aug 22, 2019 · Terminated
  iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
• Z-0064-2020 · Aug 22, 2019 · Terminated
  iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 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