S-ROM 1365-64-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295034179), received between Feb 16, 2021 and Mar 30, 2023 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN IN HIP FROM METAL ON METAL CONSTRUCT. REVISED TO METAL ON POLY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN . THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 16642612 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PSEUDOTUMOR COMPRESSING THE EXTERNAL ILIAC VEIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6), 2008, DATE OF REVISION: UNK, DATE OF EVENT: (B)(6) 2023, (LEFT HIP). TREATMENT: REVISION (REVISED COMPONENT NOT SPECIFIED).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16573166 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR METALLOSIS - LINER FAILURE - ALVAL REACTION TO METAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. ON (B)(6) 2009, THE PATIENT UNDERWENT A PRIMARY RIGHT HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DATE OF IMPLANTATION: (B)(6) 2009, DATE OF EVENT (ONSET): (B)(6) 2011, (RIGHT HIP). TREATMENT: REVISION OF METAL LINER AND METAL HEAD (BY DIFFERENT SURGEON/DIFFERENT HOSPITAL).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 11333479 ↗