S-ROM ZTT 55-0515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295175254), received between Oct 23, 2017 and Jun 30, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22358398 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SIGNIFICANT PAIN IN THE LEFT HIP. METAL ION LEVELS WERE PERFORMED AND IT SHOWED SLIGHTLY ELEVATED METAL ION. DOI: (B)(6) 2004 DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP THIS PC IS BILATERAL LINKED WITH (B)(4) RIGHT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18659634 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGED THAT PATIENT EXPERIENCED PAIN WHEN WALKING AND BENDING IN HIP AREA. THE HIP REPLACEMENT HAD BROKE IN PATIENT'S LEG.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Limb Fracture; Pain

  MAUDE report 11597874 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, CLICKING AND ELEVATED METAL ION LEVELS. UPDATE AD 24 JUL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGED PULMONARY EMBOLISM, ABDUCTOR MUSCLE REPAIR, AND DISLOCATION THE STEM, SLEEVE, AND THE CUP WERE ADDED TO THE IMPACTED PRODUCT DUE TO THE ALLEGED PULMONARY EMBOLISM FORM THE PPF. NO REVISION REPORTED FOR THE RIGHT HIP. DOI: (B)(6) 2007; DOR: NONE REPORTED, (RIGHT HIP). (B)(4) (LEFT HIP) FIRST REVISION. (B)(4) (LEFT HIP).

  Patient problems: Pain; Pulmonary Embolism; Tissue Damage

  MAUDE report 8903259 ↗
• InjuryOct 23, 2017Loose or Intermittent Connection; Migration or Expulsion of Device; Loss of Osseointegration; Loose or Intermittent Connection; Migration or Expulsion of Device; Loss of Osseointegration

  IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP AND STEM. UPDATED ASSOCIATED CONTACTS, ADDED REVISION HOSPITAL. ADDED CUP (B)(4).

  Patient problems: Inadequate Osseointegration; No Information

  MAUDE report 6968137 ↗