Continuum® Trilogy® Allofit® Longevity® 00-8758-009-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024151819), received between Aug 25, 2021 and Jan 23, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K101730, K200823); they may or may not involve this specific model.

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.

• InjuryJan 23, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING SURGERY THAT THE SURGEON WAS HAVING A PROBLEM IMPLANTING THE LINER INTO THE SHELL. THE LINER DID NOT FULLY SEAT PROPERLY WHILE IMPACTING AND POPPED OUT WHILE THE SURGEON TRIED TO FIT THE LINER INTO THE SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216371 ↗
• MalfunctionAug 31, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. DURING THE PROCEDURE, THE CONSTRAINED LINER WAS NOT PROPERLY INSERTED, AND THE SURGEON TAPPED IT FORCEFULLY, CAUSING THE LINER TO DIG INTO THE CONTINUUM SHELL. THE LINER WAS REMOVED WITH THE SHELL BECAUSE IT WAS NO LONGER REMOVABLE. THE SURGERY WAS COMPLETED WITH A NEW SHELL AND CONSTRAINED LINER. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662389 ↗
• InjuryDec 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF CUP 2 DAYS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13118951 ↗
• MalfunctionAug 25, 2021Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101730, K200823. One submission often covers many models, so check the product and lot details in each record.

• Z-2519-2023 · Jul 26, 2023 · Open, Classified
  M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)