S-ROM ZTT 55-0540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295175377), received between Aug 16, 2018 and Mar 7, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR MINOR PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2000. DATE OF EVENT: (B)(6) 2024. (RIGHT HIP). TREATMENT: REVISION; LINER, STEM, AND HEAD WERE REVISED.

  Patient problems: Pain

  MAUDE report 18861292 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR SUPPLEMENTAL INFO AND MEDICAL RECORDS WERE RECEIVED. AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS RIGHT TOTAL HIP ARTHROPLASTY FAILURE SECONDARY TO LEG-LENGTHENING EXCESSIVELY AND CALCAR FRACTURE. OPERATIVE NOTE REPORTED THAT THE FEMORAL NECK WAS NOTED TO HAVE CRACKED DURING THE INSERTION OF THE NEW STEM. DOI: (B)(6) 2009, DOR: (B)(6) 2010, RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 11119005 ↗
• InjuryOct 14, 2019Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS REPORTED THAT SINKING OF IMPLANT WAS CONFIRMED FOR THE PATIENT WHO HAD BEEN PERFORMED THE PRIMARY SURGERY VIA THA, AND THE 1ST, REVISION SURGERY VIA ETO BY SCRAPING CEMENT AND IMPLANTING S-ROM AT (B)(6) (DATE ON THOSE SURGERY WERE UNKNOWN). THUS, THE 2ND, REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2019 BY REPLACING S-ROM IMPLANT (P/N: UNKNOWN) ON THE PATIENT'S LEFT HIP JOINT AT (B)(6) HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9187396 ↗
• InjuryJun 11, 2019Loss of Osseointegration; Loss of Osseointegration

  NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT (B)(4). THE PATIENT WAS REVISED BECAUSE OF INFECTION AND CUP LOOSENING. UPDATE AD 21 MAY 2019. (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF PINNACLE CLAIM SUBMISSION FORM, IMPLANT AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS SEPTIC LOOSENING. OPERATIVE FINDINGS INCLUDE INFLAMMATORY TISSUES, LOOSE CUP AS WELL AS STEM, A LARGE FLUID COLLECTION WITHIN THE JOINT AND NECROTIC TISSUE. REVISION IMPLANTS ARE FROM DEPUY. ANTIBIOTIC-LADEN CEMENT WAS USED ON THE ACETABULUM AND FEMORAL CANAL. THESE WERE REMOVED 3 MONTHS AFTER AS PLANNED WITH NO COMPLICATIONS. DOI: (B)(6) 2011 - DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Inflammation; Necrosis; No Code Available; Unspecified Infection

  MAUDE report 8688131 ↗
• InjuryApr 29, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2011; DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 8559966 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF ALLEGES INFECTION REQUIRING INTRAVENOUS ANTIBIOTICS AFTER FIRST REVISION. DOI: (B)(6) 2008 -DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 7788491 ↗