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S-ROM ZTT 55-0516Recalls & reported problems

Depuy (Ireland) · S-ROM Modular Hip System ZTT Proximal Sleeve POROUS COATED 16 F LRG FITS: 16 x 11 STEM Cone: F Triangle: LRG · Class 3 · Implant

All models of S-ROM ZTT (36)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295175261), received between Jan 16, 2018 and Mar 21, 2019 — classified as 3 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Fracture1
  • Loose or Intermittent Connection1
  • Loss of Osseointegration1

Patient problems

  • Inadequate Osseointegration2
  • Pain2
  • Discomfort1
  • Loss of Range of Motion1
  • Not Applicable1
  • Osteolysis1
  • Swelling1
  • Tissue Damage1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 21, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

    PPF AND IMPLANT RECORD RECEIVED. PPF ALLEGES FRACTURE(COMPONENT) AND LOOSENING OF STEM. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

    Patient problems: Inadequate Osseointegration

    MAUDE report 8440138 ↗
  • InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PPF ALLEGES PSEUDOTUMOR AND INFECTION. DOI: (B)(6) 2006 - DOR: (B)(6) 2013; (LEFT HIP).

    Patient problems: Discomfort; Loss of Range of Motion; Osteolysis; Pain; Swelling; Tissue Damage; Unspecified Infection

    MAUDE report 8319773 ↗
  • InjuryApr 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO THE LOOSENING OF THE IMPLANTED STEM IN VARUS AND LOOSENING OF THE SLEEVE. THE CUP WAS DECIDED TO KEEP INSIDE OF THE PATIENT¿S HIP JOINT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Patient problems: Inadequate Osseointegration; Not Applicable

    MAUDE report 7398838 ↗
  • InjuryJan 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    LITIGATION PAPERS ALLEGE PAIN, DECREASED RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. UPDATE - (B)(6) 2014 - PLAINTIFF¿S FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FROM PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. COMPLAINT WAS UPDATED ON (B)(6) 2014. UPDATE (B)(6) 2017: MEDICAL RECORDS RECEIVED. UPDATED THE PRODUCT DETAILS. ADDED THE TAPER SLEEVE ADAPTOR, PROXIMAL SLEEVE AND THE STEM FOR THE ALLEGED ELEVATED METAL ION LEVELS. THERE IS NO REVISION NOTE AND LABORATORY VALUES PROVIDED. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2017.

    Patient problems: Pain

    MAUDE report 7192870 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices →

Sources and updates

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