iTotal® Hip Replacement System HDL060E34S01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M572HDL060E34S011), received between Aug 6, 2019 and Aug 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2019Failure to Align

  IT WAS REPORTED THAT THE PLUS 4 CUP LINER WOULD NOT LOCK IN OR SEAT INSIDE THE CUP AFTER FIVE DIFFERENT ATTEMPTS. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE STANDARD PLUS 2 LINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8865133 ↗

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