S-ROM ZTT 55-0570Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295175506), received between May 3, 2019 and Jun 19, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE AND LOOSE STEM. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19568011 ↗
• InjuryNov 1, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PFS AND MEDICAL RECORDS RECEIVED. LAB LEVELS PROVIDED FOR METAL ION LEVELS INDICATED THE METAL ION LEVELS ARE ABOVE 7PPB. THE STEM HAS ALREADY BEEN REPORTED ON (B)(4). A POLY LINER IS IMPLANTED AND NO REVISION DATE HAS BEEN PROVIDED. UPDATE AD 8 AUG 2018: (B)(4) WAS RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF, STICKER SHEETS AND IMPLANT RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES DISLOCATION, LOOSE CUP AND STEM, AND BONE FRACTURE. ADDED CUP, SCREW, LINER AND SLEEVE TO THE COMPLAINT. THE STEM HAS BEEN REPORTED ON (B)(4). ADDED LAW FIRM AND LAWYER. UPDATED PATIENT INITIALS. AT THIS TIME IT¿S UNKNOWN WHERE THE FRACTURE OCCURRED. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. DOI: (B)(6) 2005 (CUP,SCREW,SLEEVE); DOI: (B)(6) 2009 (HEAD AND LINER); DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9267505 ↗
• InjuryMay 3, 2019Corroded; Loss of Osseointegration; Corroded; Loss of Osseointegration

  ADDITIONAL INFORMATION RECEIVED: AD 24 JUNE 2019. THERE WAS A CORROSION BETWEEN THE HEAD NECK JUNCTION AND CORROSION BETWEEN THE STEM AND SLEEVE.

  Patient problems: Inadequate Osseointegration; No Code Available; Not Applicable; Pain

  MAUDE report 8577941 ↗