S-ROM ZTT 55-0728Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295175582), received between Mar 9, 2020 and Mar 9, 2020 — classified as 1 injury.

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.

• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO ADVERSE TISSUE RESPONSE. LAB WORK SHOWED AN INCREASE IN COBALT CHROMIUM LEVELS AS SHE BEGAN HAVING PAIN. OPERATIVE NOTES INDICATED THAT THE PATIENT HAD A LARGE FLUID-FILLED SOFT TISSUE MASS OVER THE GREATER TROCHANTER AND EXPANSION OF HER TROCHANTERIC BURSA. THE BURSA WAS FILLED WITH A CLOUDY WHITE FLUID CONSISTENT WITH THAT SEEN IN METAL WEAR REACTION. THERE WAS A GREAT DEAL OF LYTIC WEAR DEBRIS SPREAD THROUGHOUT THIS LARGE SAC. THE GREATER TROCHANTER HAD AREAS OF LYSIS, AS DID THE MEDIAL NECK. THERE WAS EVIDENCE OF FRETTING CORROSION ON THE TAPER. THERE WERE LARGE AREAS OF LYSIS PRESENT BEHIND THE CUP. THE LARGE HEAD BALL WAS DISIMPACTED FROM THE TAPER AND FRETTING CORROSION WAS VISIBLE. ADDITIONALLY, IT WAS ALSO REPORTED THAT DURING THE PRIMARY HIP REPLACEMENT SURGERY, A SMALL CRACK OCCURRED ANTERIORLY IN THE NECK DURING IMPACTION OF THE STEM, IT WAS ELECTED TO PASS A 2 MM CERCLAGE CABLE AROUND THE FEMUR TO PREVENT CRACK EXTENSION.

  Patient problems: Fatigue; Foreign Body Reaction; Injury; Metal Related Pathology; No Code Available; Osteolysis; Pain; Test Result; Weakness

  MAUDE report 9807006 ↗