S-ROM 56-3120NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295177852), received between Nov 26, 2018 and Sep 23, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE RIGHT HIP. THERE WAS AN OPEN WOUND, SWELLING, PAIN AND PUS. OPERATIVE NOTE REPORTED PUS ENCOUNTERED, CUP WAS LOOSED, BONE STOCK EXTREMELY DEFICIENT AND PATIENT HAD A MULTIPLE ALLERGIES. SURGICAL PATHOLOGY REPORTED ACUTE INFLAMMATION AND NECROSIS CONSISTENT WITH ACUTE OSTEOMYELITIS OF THE IMPLANTS PORTIONS OF BONE ARE IRREGULARLY SHAPED AND MARKEDLY DISRUPTED WITH ATTACHED TAN-PINK TO RED BROWN SOFT TISSUES AND BLOOD CLOT. DOI: (B)(6) 2008; DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Inflammation; Injury; Necrosis; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 9107737 ↗
• InjuryJan 14, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN. UPDATE (B)(6) 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ELEVATED METAL IONS.

  Patient problems: Pain; Test Result

  MAUDE report 8243645 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  LITIGATION ALLEGES THAT PATIENT'S IMPLANT FAILED, RESULTING IN REVISION SURGERY. UPDATE THERE WAS NO NEW ALLEGATION. IT WAS INDICATED IN THE PPF THAT THE STEM WAS REMOVED. CURRENTLY, SPECIFIC PATIENT HARM OR PRODUCT FAILURE IS UNKNOWN. DOI: (B)(6) 2003 - DOR: (B)(6) 2008 (LEFT HIP).

  Patient problems: No Code Available

  MAUDE report 8103216 ↗