S-ROM 52-6678Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295171430), received between Sep 13, 2018 and Oct 4, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Corroded” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2018Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  PATIENT ALLEGES THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND HIP AREA, AS WELL AS HIS GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HIS LEFT HIP. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 7934691 ↗
• InjurySep 13, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE REC¿D 4/2/2014: PFS WAS RECEIVED FROM LEGAL, PRIMARY MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE THAT DURING SURGERY THE CALCAR WAS CRACKED WHEN INSERTING THE FEMORAL SLEEVE. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE COMPLAINT WAS UPDATED ON: 4/28/2014. UPDATE AD 24 APR 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. THERE ARE NO NEW ALLEGATIONS AND NO REVISIONS REPORTED. UPDATED PATIENT'S DATE OF BIRTH. ADDED STEM DUE TO PREVIOUSLY ALLEGED TOXIC METAL IONS. UPDATED PRODUCT AND LOT NUMBER OF HEAD, LINER, AND SLEEVE. DOI: (B)(6) 2003; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Bone Fracture(s); Discomfort; Inflammation; Pain; Test Result

  MAUDE report 7873424 ↗