Tritanium 500-03-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327040012), received between Sep 28, 2017 and May 7, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2022Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  THIS PI IS FOR THE PATIENT'S RIGHT HIP, WHICH HAS BEEN REVISED. IT WAS REPORTED THAT THE PATIENT HAS BILATERAL STRYKER HIPS. THE ACETABULAR SHELLS FOR BOTH SIDES HAVE 'SPUN OUT' AND ARE NOW ORIENTED VERTICALLY AND RETROVERTED. PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2022 (SHELL, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER). THE SURGEON PLANS TO REVISE THE PATIENT'S LEFT HIP, DATE CURRENTLY UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14321164 ↗
• MalfunctionSep 28, 2017Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  THE PRODUCT WAS PACKAGED OFF CENTER IN THE PLASTIC TUB AND THE ROUGH SURFACE OF THE SHELL RUBBED AGAINST THE PLASTIC. IT CREATED PLASTIC PARTICLES IN THE SHELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901507 ↗