S-ROM ZTT 55-0503Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295175193), received between Jan 31, 2018 and Mar 15, 2022 — classified as 4 injuries, 1 malfunction.

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

• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR, ELEVATED METAL IONS, NEUROLYSIS OF SCIATIC NERVE, COMPLEX WOUND OF HIP, HETEROTOPIC OSSIFICATION AND CAPSULAR REDUNDANCY. OPERATIVE NOTE REPORTED SCARS, METALLOSIS, PSEUDOTUMOR AND METALLIC DEBRIS. THERE WAS A LARGE AMOUNT OF FLUID PRESENT IN THE HIP JOINT, SCIATIC NERVE WAS COMPRESSED BY THE PSEUDOTUMOR. THERE WAS ALSO A LARGE AMOUNT OF CAPSULAR DEBRIS, PSEUDOTUMOR AND SOME HETEROTOPIC BONE. MEDICAL RECORDS INDICATE THE CUP WAS LOOSENED AND CYSTIC CHANGES WERE CURETTED FROM BEHIND THE CUP. DOI: (B)(6) 2009; DOR: (B)(6) 2012 ; RIGHT HIP.

  Patient problems: Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Nerve Damage; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 13769631 ↗
• MalfunctionFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY VIA TKA. THIS PC REPORTS ABOUT THE REVISION SURGERY WAS PERFORMED DUE TO THE ACCUMULATION OF THE WATER IN PSEUDOTUMOR EXCISION SITE. AFTER THE REMOVAL SURGERY OF PSEUDOTUMOR PERFORMED IN (B)(6) 2021, IT WAS FOUND THAT THE ACCUMULATION OF THE WATER IN PSEUDOTUMOR EXCISION SITE. THE PATIENT WAS SUSPECTED OF HAVING AN INFECTION, SO THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, AND THE IMPLANTS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema; Unspecified Infection

  MAUDE report 13558366 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE REVISION SURGERY WAS PERFORMED DUE TO THE ACCUMULATION OF THE WATER IN PSEUDOTUMOR EXCISION SITE. THIS PC REPORTS ABOUT THE PRIMARY SURGERY. IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE PRIMARY SURGERY, ON AN UNKNOWN DATE, PSEUDOTUMOR WAS IDENTIFIED IN MUSCLE TISSUE. ON AN UNKNOWN DATE, (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY OF PSEUDOTUMOR, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12917198 ↗
• InjuryAug 22, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA THA. IT WAS REPORTED THAT THE PATIENT COMPLAINED PAIN AND THE STEM BREAKAGE WAS REVEALED BY X-RAY WHEN SHE VISITED TO THE HOSPITAL. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE STEM (P/N: 900527210) WITH THE SLEEVE (P/N: 550503) TO SIZE 18-12 DUE TO PAIN, DISTAL-STEM BREAKAGE, LOOSENING OF THE SLEEVE. THE SURGERY WAS COMPLETED WITHOUT PROBLEM, AND THE SIZE OF THE SURGICAL WOUND WAS THE SAME AS THE PRIMARY SURGERY. IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. DR¿S COMMENT: THE SLEEVE CAME OFF WITH THE STEM STUCK TOGETHER WHEN THE SURGEON ATTEMPTED TO REMOVE ONLY THE STEM, SO IT WAS CONSIDERED THAT THE STEM WAS BROKEN BY THE STRESS TO THE DISTAL END DUE TO THE LOOSENING OF THE SLEEVE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8920803 ↗
• InjuryJan 31, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2015; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7230190 ↗