S-ROM 56-3118NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295177821), received between Sep 8, 2017 and Mar 28, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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 28, 2022Fracture; Fracture

  PATIENT HAS HAD SEVERAL REVISIONS IN THE PAST 20 YEARS. MOST RECENT REVISION COMPLETED DUE TO INSTABILITY. IT WAS DISCOVERED DURING SURGERY THAT THE SROM FEMAL STEM FRACTURED. A PIECE OF THE STEM WAS LEFT BEHIND IN THE FEMORAL CANAL. SURGEON EXCHANGED THE FEMORAL HEAD AND REMOVED THE ESCA ALUMINA CERAMIC ACETABULAR BEARING THAT WAS ORIGINAL FROM THE PRIMARY SURGERY. A CONSTRAINED LINER WAS IMPLANTED. PRIMARY SURGERY - RIGHT HIP; APPROXIMATELY 20 YEARS AGO - DETAILS UNKNOWN. ESCA HIP IMPLANTED (NO DEPUY PRODUCTS INVOLVED). REVISION 1: *REVISION OF ESCA PRODUCTS* (B)(6) 2009, (B)(6) HOSPITAL, DR. (B)(6). USAGE: 563118N, SROM*STM LG 36+8L 18X13X215N, 2783353; 550727, S-ROM*SLVE ZTTOVSZ 20F-SML18ID, 2785308; 528323, S-ROM*HEAD FEMRL ALUMINA 32+0, 2224752. REVISION 2 ((B)(4)- CURRENT PC). *REVISION OF DEPUY PRODUCTS - ESCA PRODUCTS LEFT IN SITU* (B)(6) 2015, (B)(6) HOSPITAL, DR. (B)(6) . USAGE: 523420, S-ROM STM ST 36+8L NK 20X15X16, 7774624; 550738, S-ROM SLEEVE ZTTOVSZ 22F-LRG20ID, 3200641; 136532210, DELTA CER HEAD 11/13 32MM +0, 8042154. REVISION RIGHT HIP (B)(4). *REVISION OF BOTH ESCA AND DEPUY PRODUCTS* (B)(6) 2022, (B)(6) HOSPITAL, DR. (B)(6). USAGE: 522028, S-ROM HEAD FEMORAL C

  Patient problems: Insufficient Information

  MAUDE report 13930428 ↗
• InjuryNov 5, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION PAPERS ALLEGE: SUSTAINED AND CONTINUES TO SUFFER ECONOMIC DAMAGES (INCLUDING MEDICAL AND HOSPITAL EXPENSES) SEVERE AND POSSIBLY PERMANENT INJURIES, DISABILITY, DISFIGUREMENT, PAIN, SUFFERING AND EMOTIONAL DISTRESS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. ADDED STEM DUE TO THE ALLEGED LOOSENING. DOI: (B)(6) 2007; DOR: (B)(6) 2009; (RIGHT HIP).

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8039768 ↗
• InjurySep 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS THIGH PAIN. THE PATIENT WAS EXPERIENCING THIGH PAIN, POTENTIALLY DUE TO THE STEM BEING LOOSE AS THE IMPLANTS WERE EASILY REMOVED.

  Patient problems: Pain

  MAUDE report 6853038 ↗