S-ROM ZTT 55-0568Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295175483), received between Mar 9, 2020 and Mar 9, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2020Loss of Osseointegration; Loss of Osseointegration

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT. REVISION NOTES REPORTED FEMORAL COMPONENT WAS GROSSLY LOOSE AND WAS REMOVED. PATIENT HAD MARKED DEFORMITY IN FEMUR. LINER WAS LOOSENED. HEAD,LINER, AND STEM WERE REMOVED. PATIENT EXPERIENCED PAIN, SWELLING,PSEUDOTUMOR, HAD BLOOD ON THE ASPIRATE AND POSSIBLE METALLOSIS. DOI: (B)(6) 2011; DOR: (B)(6) 2017; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain; Swelling

  MAUDE report 9808380 ↗