S-ROM ZTT 52-1403Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295170570), received between Oct 9, 2018 and Dec 2, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REVISED FEMORAL COMPONENTS AND REPLACED WITH A COMPETITOR REVISION STEM. PATIENT HAD TRAUMA TO THE HIP AND THE STEM BECAME LOOSE. PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20825214 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION COMPLAINT RECEIVED AD 31 JAN 2022. LITIGATION RECORDS ALLEGES PAIN, INJURY ECONOMIC LOSS, PUNITIVE DAMAGES, EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2008. DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pulmonary Embolism

  MAUDE report 14286631 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020 DUE TO PAIN. THERE WAS SUSPICION OF ARMD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10162481 ↗
• InjuryAug 9, 2019Use of Device Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Migration; Use of Device Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Migration

  LITIGATION ALLEGES PAIN, INSTABILITY AND ELEVATED METAL ION LEVELS. MEDICAL RECORDS REPORTED PAIN WITH WEIGHT BEARING AN A RADIOGRAPH REPORTEDLY SHOWED MILD VARUS SHIFT OF THE FEMORAL COMPONENT SUGGESTING LACK OF INGROWTH AND SEVERE OSTEOPOROSIS. UPDATE AD 25 JUL 2018:(B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND IMPLANT RECORD. PPF ALLEGES INFECTION, METALLOSIS AND METAL WEAR. UPDATED DOR, AGE, LAWYER AND LAW FIRM. ADDED IPS FOR THE PATIENT HARM. DOI: (B)(6) 2007 - DOR: (B)(6) 2018, (RIGHT HIP).

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

  MAUDE report 8879281 ↗
• InjuryApr 22, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM AND FRACTURE (BONE). DOI: (B)(6) 2009 - DOR: (B)(6) 2014 (LEFT HIP)

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 8535258 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LITIGATION ALLEGES LOOSENING OF CUP AND INFECTION. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Pain; Unspecified Infection; Weakness

  MAUDE report 7946565 ↗