S-ROM ZTT 52-1405Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295170587), received between Jan 26, 2018 and Jul 27, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND WORSENING FUNCTION, ELEVATED COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2006. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP. THIS PC IS BILATERAL HIP ARTHROPLASTY LINKED TO PC-(B)(4) RIGHT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17406161 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND WORSENING FUNCTION , ELEVATED COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2006. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP. THIS PC IS BILATERAL HIP ARTHROPLASTY LINKED TO (B)(4). LEFT HIP ARTHROPLASTY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17397005 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASSOCIATED STUDY: PINNACLE CUP, PINNACLE CUP. DATE OF EVALUATION: (B)(6) 2017. DATE OF ONSET: (B)(6) 2020. DIAGNOSIS: INFECTION. ADVERSE EVENT: INFECTION - SUPERFICIAL.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 9979113 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOSPITAL´S PURCHASING DEPARTMENT IS ASKING FOR THE POSSIBILITY TO ORDER THIS PRODUCT AS A PATIENT SPECIFIC IMPLANT. THIS REQUEST IS ENTERED AS A COMPLAINT AS IT MIGHT BE RELATED TO A PLANNED REVISION.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 9799434 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2014. (HEAD & LINER). DOI: (B)(6) 2010. (CUP, SCREW, SLEEVE & STEM). DOR: (B)(6) 2015. LEFT HIP. SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9156147 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES STROKE/HEART ATTACK, METAL WEAR AND METALLOSIS BEFORE FIRST REVISION.

  Patient problems: Cardiac Arrest; Infarction, Cerebral; No Code Available; Tissue Damage

  MAUDE report 8210366 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES LOOSENING OF CUP AND INFECTION. DOI: (B)(6) 2009 - DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Not Applicable; Pain; Unspecified Infection; Weakness

  MAUDE report 7946793 ↗
• InjuryJan 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE COMPLICATION OF FEMORAL BONE FRACTURE. EVENT IS SERIOUS. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. TREATMENT INCLUDES ORIF OF NONDISPLACED TROCHANTERIC FRACTURE. DOI: (B)(6) 2018. DOE: (B)(6) 2018. (LEFT HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 7221228 ↗