S-ROM 52-8330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295171485), received between Nov 25, 2020 and Jan 18, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (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 16, 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.

• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO RIGHT HIP PAIN AND HIGH COBALT LEVELS. INTRA-OPERATIVE FINDINGS INCLUDE YELLOW TINGED EFFUSION, SYNOVITIS, TRUNNION CORROSION, BACK SIDED METAL LINER CORROSION AND METALLOSIS. METAL HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain; Swelling/ Edema; Synovitis; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 11186575 ↗
• InjuryNov 25, 2020Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES DATED (B)(6) 2020 INDICATED THAT THE PATIENT RECEIVED A LEFT TOTAL HIP REVISION DUE TO BEARING WEAR OF THE ARTICULATING METAL SURFACE. UPON ENTERING THE JOINT, EXTENSIVE CHRONIC INFLAMMATION WAS ENCOUNTERED. MILD CORROSION WAS IDENTIFIED ON THE FEMORAL HEAD AND TRUNNION OF THE STEM. THE BACKSIDE OF THE LINER AND TOPSIDE OF THE CUP SHOWED BROWN-RED METALLOSIS. THE LINER AND HEAD WERE REVISED, CUP AND STEM WERE NOTED TO BE WELL FIXED, CLEANED AND LEFT IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 10905468 ↗