ASPHERE 1365-54-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295033981), received between Feb 13, 2013 and Feb 5, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED DUE TO PAINFUL LEFT FAILED TOTAL HIP ARTHOPLASTY. DOI: (B)(6) 2010 DOR: (B)(6) 2019 LEFT HIP.

  Patient problems: Pain

  MAUDE report 11289859 ↗
• InjuryNov 26, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 8102085 ↗
• InjuryOct 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PENDING PRODUCT LIABILITY, CUSTOMER ALLEGES DISLOCATION WITH A CLOSED REDUCTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7924201 ↗
• InjuryFeb 13, 2013Appropriate Device Problem Term/Code Not Available; Noise, Audible

  PATIENT WAS REVISED TO ADDRESS A SQUEAKY HIP AND GROIN PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 2959366 ↗