S-ROM 56-3122RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295177890), received between Dec 10, 2018 and Dec 10, 2018 — 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.

• InjuryDec 10, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN AND DISCOMFORT, SWELLING IN HIS LEG, AND DIFFICULTY SLEEPING. DURING SURGERY A CRACK WAS FOUND WHILE PUTTING IN THE SLEEVE. PATIENT WAS REVISED BECAUSE OF A LOOSE STEM AND THE CUP WAS RETROVERTED. PATIENT WAS REVISED TO ADDRESS FAILED RIGHT HIP ARTHROPLASTY. PATIENT SCAR TISSUE WAS EXCISED CIRCUMFERENTIALLY AROUND THE HIP. HIS FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED AFTER INSPECTION AND THERE WERE OTHER UNUSUALITY NOTED DURING THE OPERATION. DOI: (B)(6) 2010 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8145940 ↗