ASPHERE 1365-26-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295033233), received between Nov 29, 2018 and Dec 15, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Disintegration” (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.

• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS LEFT HIP ABDUCTOR AVULSION. PATIENT HAD PAIN, LIMP AND WEAKNESS IN LEFT HIP. PATIENT HAD LEFT ABDUCTOR FAILURE AND ABDUCTION. THERE WAS SCAR TISSUE BETWEEN THE ABDUCTORS AND THE MUSCULOTENDINOUS CUFF. DOI: (B)(6) 2012. DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fatigue; Muscle/Tendon Damage; Pain

  MAUDE report 11011892 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 8265163 ↗
• InjuryNov 29, 2018Material Disintegration; Material Disintegration

  LITIGATION ALLEGES PSEUDOTUMOR, METALLOSIS, METAL WEAR, ELEVATED METAL IONS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8116913 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR, METALLOSIS, METAL WEAR, ELEVATED METAL IONS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8116819 ↗