S-ROM 52-3424Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295171065), received between Apr 6, 2018 and Nov 8, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, POPPING, AND DIFFICULTY AMBULATING. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. PPF ALSO REPORTS THAT THE PATIENT IS DECEASED, BUT DOES NOT INDICATE THAT THIS WAS AT ALL PRODUCT RELATED, NOR PROVIDES A DATE OF DEATH. DOI: (B)(6) 2005 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Death; Discomfort; Pain; Test Result

  MAUDE report 8051038 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, POPPING, AND DIFFICULTY AMBULATING. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Death; Discomfort; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 8050878 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS TRUNIOSIS AND HIGH METAL ION LEVELS. IT WAS ALSO INDICATED THAT PATIENT WAS REVISED TO A POLY LINER AND CERAMIC HEAD WITH A NEW STEM. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Host-Tissue Reaction; No Code Available; Not Applicable; Tissue Damage

  MAUDE report 7494578 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES METALLOSIS, FATIGUE, SWELLING, INFLAMMATION, DISLOCATION, HEADACHES, HEARING LOSS, PSEUDOTUMOR, NECROSIS, DETERIORATION AND INSTABILITY OF THE RIGHT HIP, GASTROINTESTINAL PROBLEM, CHOLECYSTITIS AND GALLBLADDER REMOVAL. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS LARGE PSEUDOTUMOR CAUSING SOFT TISSUE DESTRUCTION AND SIGNIFICANT METALLOSIS WITH CYSTIC CHANGES. REVISION NOTES REPORTED ELEVATED METAL IONS, ASPIRATED TURBID DARK BLACK FLUID AND METALLOSIS WITHIN THE SYNOVIAL TISSUE. THE SCREW WAS REMOVED AND THE CUP IS WELL FIXED. CLINICAL NOTES STATED THAT PATIENT PREVIOUSLY FELL AND DISLOCATED AND WAS REDUCED IN ER. MRI SHOWED A SIGNIFICANT PSEUDOTUMOR. DOI: (B)(6) 2002; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Cyst(s); Fatigue; Headache; Hearing Impairment; Inflammation; Injury; Necrosis; No Code Available; Not Applicable; Swelling; Tissue Damage

  MAUDE report 7402695 ↗