S-ROM ZTT 55-0520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295175278), received between May 16, 2018 and Dec 4, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF STEM. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18256666 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL PARTS AND PUT SPACER IN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7597143 ↗
• InjuryMay 16, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF SLEEVE AND STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7517787 ↗