S-ROM 1365-41-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295033738), received between Sep 20, 2017 and Oct 4, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2018Corroded; Naturally Worn; Insufficient Device Problem Information; Corroded; Naturally Worn; 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 7934686 ↗
• MalfunctionJan 29, 2018Material Disintegration; Metal Shedding Debris; Insufficient Device Problem Information; Material Disintegration; Metal Shedding Debris; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS GROIN PAIN. DOI: (B)(6) 2010. DOR: (B)(6) 2018. LEFT HIP.

  Patient problems: Discomfort; Distress; Inflammation; Injury; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7224504 ↗
• InjuryDec 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS METALLOSIS.

  Patient problems: Tissue Damage

  MAUDE report 7113582 ↗
• InjurySep 20, 2017Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information; Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information

  PPF ALLEGES DISLOCATION, METAL WEAR/METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Host-Tissue Reaction; Joint Dislocation; No Code Available; Pain

  MAUDE report 6879042 ↗
• InjurySep 20, 2017Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information; Device Dislodged or Dislocated; Naturally Worn; Insufficient Device Problem Information

  PPF ALLEGES DISLOCATION, METAL WEAR/METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Host-Tissue Reaction; Joint Dislocation; No Code Available; Pain

  MAUDE report 6878754 ↗