S-ROM ZTT 55-0544Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295175391), received between Dec 10, 2018 and May 14, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A RIGHT TOTAL HIP REPLACEMENT DUE TO SEVERE, DEGENERATIVE ARTHRITIS. PATIENT WAS REVISED TO ADDRESS PAIN AND INFECTED HIP. ASR CONSTRUCT REVISED. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOR: JUN 11, 2018; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Pain; Unspecified Infection

  MAUDE report 19315251 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE BILATERAL PATIENT SUFFERED AND CONTINUES TO SUFFER SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, WEAKNESS, DIFFICULTY WALKING, TROUBLE PU-TTING ON SHOES, DECREASED RANGE OF MOTION, AND DIFFICULTY WITH EVEN SIMPLE DAILY LIVING ACTIVITIES. ADDITIONALLY IT IS ALLEGED THAT, THE PATIENT SUFFERS FROM ELEVATED COBALT METAL IONS IN HIS BLOOD STREAM AS A RESULT OF THE METAL ON METAL IMPLANTS. UPDATE (B)(4) 2011 :PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED. DOB UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE (B)(4) 2016: LITIGATION RECEIVED. THE STEM AND TAPER SLEEVE ARE BEING ADDED TO THE COMPLAINT FOR THE ALLEGED HIGH METAL ION LEVELS. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2016.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Weakness

  MAUDE report 9823583 ↗
• InjuryDec 10, 2018Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN AND DISCOMFORT, SWELLING IN HIS LEG, AND DIFFICULTY SLEEPING. DURING SURGERY A CRACK WAS FOUND WHILE PUTTING IN THE SLEEVE. PATIENT WAS REVISED BECAUSE OF A LOOSE STEM AND THE CUP WAS RETROVERTED. PATIENT WAS REVISED TO ADDRESS FAILED RIGHT HIP ARTHROPLASTY. PATIENT SCAR TISSUE WAS EXCISED CIRCUMFERENTIALLY AROUND THE HIP. HIS FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED AFTER INSPECTION AND THERE WERE OTHER UNUSUALITIES NOTED DURING THE OPERATION. DOI: (B)(6) 2010, DOR: JUL 29, 2011, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8145913 ↗