S-ROM ZTT 52-1425Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295170600), received between Jul 18, 2018 and May 12, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION REPORTED THAT THE PLAINTIFFS REVISION INVOLVED, IN PART, A FINDING OF AN ADVERSE TISSUE REACTION RELATED TO THE METAL-ON-METAL ARTICULATION, RELEASE OF A LARGE AMOUNT OF BROWNISH FLUID, AND DEBRIDEMENT AND REMOVAL OF BROWNISH FRIABLE TISSUE THROUGHOUT THE ENTIRE HIP JOINT, ALL DUE TO TOXIC HEAVY METAL/METAL ION COBALT AND CHROMIUM POISONING.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Arrhythmia; Depression; Discomfort; Distress; Dyspnea; Extraskeletal ossification; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limb Fracture; Loss of Range of Motion; Muscle/Tendon Damage; Numbness; Pain; Paresthesia; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11814315 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM INFLAMMATION, PAIN, TISSUE AND BONE LOSS, AND ELEVATED COBALT AND CHROMIUM LEVELS. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES INJURY. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RIGHT TOTAL HIP ARTHROPLASTY, METAL-ON-METAL COMPONENTS WITH INCREASED CHROMIUM LEVELS, AND INCREASE IN PAIN. REVISION NOTES REPORTED INFECTION, ACETABULAR COMPONENT AND THE LINER HAD BROKEN LOOSE AND NOT COMPLETELY RELEASED AWAY IN NORMAL POSITION AND ROTATED THE SCREWS, CAUSED MEDIAL MIGRATION AND SUBSIDENCE OF COMPONENTS. DOI: (B)(6) 2008 - DOR: (B)(6) 2016 (RIGHT HIP).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; No Code Available; Unspecified Infection

  MAUDE report 8590491 ↗
• InjuryJul 18, 2018Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, IMMOBILITY, INFLAMMATION AND HIGH LEVELS OF CHROMIUM AND COBALT. UPDATE AD MAY 29, 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM. UPDATED PRODUCT AND LOT NUMBER OF INSERT (121887356/2136865), HEAD ( 136531000/2193018), STEM ( 523422/2160316), CUP (121722056/A5WFX1000).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Loss of Range of Motion; Pain; Test Result; Unspecified Infection

  MAUDE report 7698176 ↗