S-ROM ZTT 55-0543Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295175384), received between Jun 29, 2017 and Nov 17, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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.

• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP; SURGEON EXPLANTED COMPONENTS AND IMPLANTED PROSTALAC SPACER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10853696 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORDS RECEIVED ALLEGING ELEVATED BLOOD METAL ION LEVELS, INJURY, PAIN AND SUFFERING. DOI: (B)(6) 2007 - DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Inflammation; Necrosis; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 9416015 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD UNDERGONE A RIGHT HIP RESECTION SURGERY POSSIBLY DUE TO EITHER INFECTION OR METALLOSIS. THERE APPEARED TO BE SOME RENT IN THE GLUTEUS MAXIMUS FASCIA AND GLUTEUS MAXIMUS PROXIMALLY WHICH MADE THESE DIFFICULT TO IDENTIFY. THE FEMORAL CUP WAS NOTED TO BE LOOSE. A GRAY, CHEESY-APPEARING PSEUDOCAPSULE, WHICH WAS CONSISTENT WITH METALLOSIS WAS REMOVED. SURGEON NOTES THAT THERE WAS MARKED DEAD BONE ABOUT THE CUP. THERE WAS ALSO SOME HETEROTROPHIC BONE. PATIENT HAD ALL IMPLANTS REMOVED AND REPLACED WITH ANTIBIOTIC CEMENT. IT IS UNKNOWN IF THE CEMENT USED WAS DEPUY. ADDITIONALLY, DURING THE INDEX OPERATION, THE PATIENT HAD LOST APPROXIMATELY 1400 CC OF BLOOD DUE TO THE BLEEDING FROM THE BONE AND THE ACETABULUM AFTER MACHINING AND CUTTING BONE. PATIENT RECEIVED 2700 CC OF CRYSTALLOID FLUIDS.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Necrosis; No Code Available; Pain; Unspecified Infection

  MAUDE report 9275209 ↗
• InjuryJan 16, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PAIN AND INSTABILITY. UPDATE OPERATIVE NOTES INDICATE THAT ONLY THE LINER WAS REVISED, DUE TO METALLOSIS. UPDATE PPF ALLEGES CONSTRAINED LINER, LOOSENING OF CUP, LOOSENING OF STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain; Tissue Damage

  MAUDE report 8253750 ↗
• InjuryDec 19, 2018Loss of Osseointegration; Loss of Osseointegration

  REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC AMOUNTS OF COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND WEAKNESS. PPF ALLEGES LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED TOTAL HIP ARTHROPLASTY. ADDED STEM AND PROXIMAL SLEEVE DUE TO ALLEGED LOOSENING OF STEM. DOI: (B)(6) 2003, DOR: MAY 7,2009, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain; Weakness

  MAUDE report 8178383 ↗
• InjuryJun 29, 2017Loss of Osseointegration; Loss of Osseointegration

  JUN 1, 2017. LEGAL MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES PAIN IN PATIENT'S HIPS AND THIGHS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS MECHANICAL FAILURE OF RIGHT THR SECONDARY TO RECURRENT FEMORAL LOOSENING AND HETEROTOPIC OSSIFICATION. THERE WAS NO SIGNIFICANT SYNOVITIS OR CLINICALLY OBVIOUS SIGN OF INFECTION. THERE IS HETEROTOPIC OSSIFICATION AROUND THE FEMORAL ACETABULAR COMPONENTS, WHICH WAS EXTENSIVELY DEBRIDED. THERE WAS NO OVERT SIGN OF METALLOSIS, NO PSEUDOTUMOR. THE LEG LENGTH WAS FOUND TO BE SIGNIFICANTLY SHORT BY APPROX. 1 INCH WHICH WAS EQUALIZED. THE FEMORAL STEM WAS FOUND TO BE GROSSLY LOOSE AND WAS REMOVED. LABORATORY RESULT FOR COBALT CHROMIUM ARE BELOW 7 UG/L.

  Patient problems: Pain

  MAUDE report 6677892 ↗