S-ROM ZTT 55-0550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295175421), received between Apr 29, 2019 and Apr 5, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN, PSEUDOTUMOR, AND METALLOSIS OF THE LEFT HIP SECONDARY TO FAILED METAL-ON-METAL BEARING SURFACES. IT WAS ALSO NOTED THERE WAS ATLEAST 50% LOSS OF BONE AROUND THE ENTIRE ACETABULAR COMPONENT. THE CUP WAS WELL FIXED AND FURTHER ATTEMPTS TO REMOVE THE CUP WITH PALPITATION REVEALED TO BE QUITE SOLID TO THE REMAINING BONE. THE CUP WAS NOT REMOVED. THE PATIENT'S GREATER TROCHANTER AND ENTIRE PROXIMAL FEMUR HAD DISAPPEARED SECONDARY TO OSTEOLYSIS. CT SCAN REPORTED OF LARGE PERIPROSTHETIC FLUID COLLECTION. DOI: (B)(6) 2007 DOR: (B)(6) 2022 (METAL LINER AND HEAD) LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19051321 ↗
• InjuryApr 29, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM.

  Patient problems: Inadequate Osseointegration; Pain; Test Result

  MAUDE report 8560121 ↗