S-ROM ZTT 55-0572Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295175520), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 malfunction.

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

• MalfunctionSep 3, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED IN 2008 VIA THA (THE DATE WAS UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 WHICH WAS CAUSED BY THE STEM¿S BREAKAGE AT THE SIDE OF PROXIMAL SLEEVE WITHOUT FALLING OR ANYTHING. THE SURGEON THOUGHT DIFFICULTY IN REMOVING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 10489151 ↗