IPS 60-000-64-09-LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118140357), received between Mar 12, 2025 and May 20, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THE IPS IMPLANT BROKE. IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054656 ↗
• InjuryMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THE IPS IMPLANT BROKE. IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054654 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN IPS IMPLANT AND FIBULA GRAFT WAS REMOVED AND NOT REPLACED. THERE IS NO ALLEGATION OF A PRODUCT ISSUE AT THE TIME OF REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 21588161 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN IPS IMPLANT AND FIBULA GRAFT WAS REMOVED AND NOT REPLACED. THERE IS NO ALLEGATION OF A PRODUCT ISSUE AT THE TIME OF REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 21588141 ↗