iTotal® Hip Replacement System HDL060C22S01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M572HDL060C22S011), received between Mar 26, 2025 and Jul 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Wrong Label” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Wrong Label; Wrong Label

  STANDARD ACETABULAR LINER, GROUP C, 36MM WAS INTENDED TO BE USED BUT THE BOX WAS MISLABELED AND THE SURGEON PUT IN A LIPPED, GROUP C, 36MM INSTEAD - HDL-060-C22L-000101. THE SURGEON REMOVED THE CUP AND OPENED A NEW LINER, PLACING A LARGER CUP AND STANDARD LINER CAUSING A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385172 ↗
• MalfunctionMar 26, 2025Wrong Label; Wrong Label

  DURING A HIP REPLACEMENT PROCEDURE, THE REP OPENED TWO BOXES LABELED AND STANDARD CORDERA HIP LINERS TO DISCOVER THAT BOTH BOXES CONTAINED HOODED LINERS. THE SURGEON HAD TO USE A HOODED LINER TO COMPLETE THE OPERATION INSTEAD OF THE PLANNED STANDARD LINER.

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

  MAUDE report 21699698 ↗

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