S-ROM 56-3120LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295177845), received between Apr 6, 2020 and Apr 6, 2020 — classified as 1 injury.

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 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.

• InjuryApr 6, 2020Degraded; Degraded

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS SEVERE LEFT HIP PAIN. MRI SHOWED A HEAVY BURDEN OF INTRACAPSULAR PARTICLES. REVISION NOTES STATED THAT THE PATIENT WAS NOTED TO HAVE A SIGNIFICANT SCAR TISSUE, AND DEEP TO THE FASCIA, THERE WERE LARGE AREAS OF AVASCULAR NONVIABLE SCAR TISSUE. LARGE AREAS OF AVASCULAR NECROTIC TISSUE WERE REMOVED. THE PATIENT WAS NOTED TO HAVE A LARGE BARE AREAS OVERLYING THE GREATER TROCHANTER AND THE LATERAL ASPECT OF THE PROXIMAL FEMUR. THE GRANULATION TISSUE WAS ALSO IDENTIFIED AROUND THE ACETABULAR COMPONENT. EXTENSIVE BLACK MATERIAL AROUND THE TRUNNION WAS NOTED. IT APPEARED CONSISTENT WITH CORROSION. DOI: (B)(6) 2007. DOR: (B)(6) 2010, (LEFT HIP). DOI: (B)(6) 2006, (HEAD AND LINER). THIS PC IS FOR THE SECOND REVISION OF THE LEFT HIP. PLEASE SEE (B)(4) FOR THE FIRST REVISION AND (B)(4) FOR THE RIGHT HIP.

  Patient problems: Adhesion(s); Necrosis; No Code Available; Pain

  MAUDE report 9928760 ↗