S-ROM 52-3208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295170945), received between Nov 8, 2019 and Mar 15, 2022 — classified as 2 injuries.

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.

• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR, ELEVATED METAL IONS, NEUROLYSIS OF SCIATIC NERVE, COMPLEX WOUND OF HIP, HETEROTOPIC OSSIFICATION AND CAPSULAR REDUNDANCY. OPERATIVE NOTE REPORTED SCARS, METALLOSIS, PSEUDOTUMOR AND METALLIC DEBRIS. THERE WAS A LARGE AMOUNT OF FLUID PRESENT IN THE HIP JOINT, SCIATIC NERVE WAS COMPRESSED BY THE PSEUDOTUMOR. THERE WAS ALSO A LARGE AMOUNT OF CAPSULAR DEBRIS, PSEUDOTUMOR AND SOME HETEROTOPIC BONE. MEDICAL RECORDS INDICATE THE CUP WAS LOOSENED AND CYSTIC CHANGES WERE CURETTED FROM BEHIND THE CUP. DOI: (B)(6) 2009; DOR: (B)(6) 2012 ; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Nerve Damage; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 13769624 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES SWELLING, NUMBNESS, CLICKING AND DIFFICULTY WALKING. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED ADVERSE LOCAL TISSUE REACTION. OPERATIVE NOTES INDICATED FLUID INSIDE THE HIP AS WELL AS A LINING THAT WAS METAL STAINED. DOI: (B)(6) 2008 DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Hypoesthesia; Pain; Test Result

  MAUDE report 9295015 ↗