ASPHERE 1365-32-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295033394), received between Apr 19, 2013 and Mar 5, 2020 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT COMPLAINS OF PAIN WITH SEVERE TROCHANTERIC OSTEOLYSIS ON RADIOGRAPH REPORTS. THE PATIENT WAS THEN REVISED FOR PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT HIP JOINT. OPERATIVE NOTES REPORTED THAT THE POSTERIOR SOFT TISSUE STRUCTURES WERE DEBILITATED BY EXTREME ADVERSE SOFT TISSUE REACTION. THERE WAS BROWN STAINED SYNOVIAL FLUID AND SEVERE ADVERSE SOFT TISSUE REACTION AROUND THE HIP REPLACEMENT. DOI: (B)(6) 2010; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Osteolysis; Pain; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 9792865 ↗
• InjuryNov 6, 2018Material Disintegration; Naturally Worn; Material Disintegration; Naturally Worn

  LITIGATION PAPERS ALLEGE THAT AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER 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. AS A RESULT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER RIGHT THIGH AND GROIN. PATIENT ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING AND MOVING TO AND FROM A SITTING POSITION. DOI: (B)(6) 2010; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8043126 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. THERE ARE NO ALLEGATIONS OR REVISION REPORTED. DOI: (B)(6) 2011 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Adhesion(s); Discomfort; Hearing Impairment; Host-Tissue Reaction; Inflammation; Pain; Scarring; Shaking/Tremors; Test Result; Tinnitus

  MAUDE report 7942511 ↗
• InjuryApr 19, 2013Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, INFLAMMATION, DISCOMFORT, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Host-Tissue Reaction; Inflammation; Metal Related Pathology; No Code Available; Pain; Test Result; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 3067734 ↗