S-ROM 1365-35-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295327035), received between Jul 12, 2017 and Mar 4, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Metal Shedding Debris” (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.

• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT S-ROM/PINNACLE MOM TOTAL HIP ARTHROPLASTY DUE TO PAINFUL HIP. X-RAYS SHOWED SIGNIFICANT BONE LOSS. PSEUDO TUMOR WAS REPORTED. METAL LINER RETRIEVED ALONG WITH 11/13 METAL FEMORAL HEAD. DOI: 2005; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury

  MAUDE report 18826373 ↗
• InjuryJul 12, 2017Metal Shedding Debris; Naturally Worn; Metal Shedding Debris; Naturally Worn

  ON JUN 13, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN AND SUFFERING ASSOCIATED WITH HIP REVISION WITH SURGICAL SCARRING AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT UNDERWENT SURGICAL IRRIGATION AND DEBRIDEMENT DUE TO METAL-ON-METAL COMPLICATION AND INFECTED RIGHT THA. OPERATIVE NOTES NOTED A SIGNIFICANT METALLOSIS TYPE DEBRIS AND SOME MILKY WHITE FLUID CONSISTENT WITH EITHER INFECTION OR METALLOSIS. THERE WAS ALSO NOTED TO BE SOME METALLOSIS AND NECROSIS OF THE ANTERIOR SOFT TISSUES AT THE INTERIOR AND INFERIOR BORDER OF THE ABDUCTORS. THE SIGNIFICANT PORTION OF THE TROCHANTER WAS LOADED IN FULL METAL DEBRIS. IT WAS ALSO REPORTED THAT DURING THE COMPLETING OF THE DEBRIDEMENT OF THE TROCHANTER, THEY DID NOTICE THAT PATIENT'S MEAN ARTERIAL BLOOD PRESSURE HAD SIGNIFICANTLY DECREASED. THE ANESTHESIA TEAM WAS HAVING DIFFICULTY KEEPING THIS IN APPROPRIATE RANGE WITH THE PRESSORS, SO THE MEDICAL TEAM DECIDED TO QUICKLY CLOSE THE WOUND TO ALLOW THE PATIENT RETURN TO A SUPINE POSITION AND LIKELY TRANSFER THE PATIENT BACK TO THE ICU. ON (B)(6) 2015, WHEN PATIENT WAS STABILIZED, HE UNDERWENT SURGICAL EXPLANT OF THE RIGH

  Patient problems: Foreign Body Reaction; No Code Available; Unspecified Infection

  MAUDE report 6707064 ↗