S-ROM 1365-65-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295034216), received between Sep 12, 2018 and Apr 5, 2024 — 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 18, 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.

• InjuryApr 5, 2024Degraded; Degraded

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2007: MALE PATIENT WITH A HISTORY OF LEFT HIP FEMORAL FRACTURE, LEFT HIP COMPETITOR ORIF, LEFT HIP COMPETITOR THA, ACETABULAR AND FEMORAL OSTEOLYSIS, AND CHRONIC SEPSIS INFECTION RECEIVED A DEPUY MOM REVISION THA AS STAGE 2 TREATMENT OF INFECTION. THE ACETABULAR CUP WAS SECURED WITH A DOME SCREW AND THE ACETABULAR OSTEOLYSIS REQUIRED BONE GRAFTING. THE PREVIOUS FEMORAL FRACTURE SITE WAS PARTIALLY HEALED AND REQUIRED A LARGER BONE CUT AND THE USE OF AN S-ROM STEM AND SLEEVE. THE SURGEONS NOTED THERE WAS SOME SHORTENING OF THE LEFT LEG BECAUSE OF THE PREEXISTING FRACTURE CAUSED BY AN MVA. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. CT SCAN AND PREOPERATIVE TESTING (B)(6) 2024: A MALE PATIENT IS REFERRED FOR REVISION SURGERY AFTER FAILED ATTEMPTS AT TREATING CHRONIC LEFT HIP PAIN. PREOPERATIVE ASPIRATION DOES NOT DETECT ELEVATED SERUM OR SYNOVIAL HEAVY METAL IONS BUT DOES DETECT ELEVATED INFLAMMATORY MARKERS. CT SCANS IDENTIFY A LARGE PSEUDOTUMOR AS WELL AS EXTENSIVE ACETABULAR AND FEMORAL OSTEOLYSIS. THESE WERE PREEXISTING EVENTS AND ARE PART OF THE TREATMENT OF REVISION CAPTURED ON (B)(4).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19051419 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR AND LOOSENING OF CUP. IT WAS FOUND OUT IN THE STICKER SHEETS THAT THE DEPUY PRODUCTS INVOLVED ARE THE STEM AND HEAD, THE REST ARE NON DEPUY. IT WAS ALSO INDICATED THAT THE CUP, LINER, HEAD AND STEM WERE REMOVED. DOI: (B)(6) 2009 - DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: Tissue Damage

  MAUDE report 7868069 ↗