Tritanium 500-03-56ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327040029), received between Dec 11, 2018 and Oct 17, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 23322201 ↗
• InjuryApr 8, 2025Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 21795501 ↗
• InjuryDec 5, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT CALLED STATING HE HAD A LEFT HIP REPLACEMENT DONE ON (B)(6) 2014. HE REPORTED SEVERE PAIN AND WOULD LIKE TO KNOWN IF HIS IMPLANTS WERE INVOLVED IN A RECALL. AS PER THE ATTACHED MEDICAL REVIEW," IN 2016 IT WAS NOTED THAT ON HIS X-RAYS THERE WERE SUBTLE LUCENCIES ABOUT THE ACETABULAR COMPONENT SUGGESTIVE OF LOOSENING. A BONE SCAN WAS PERFORMED AND THE RESULTS WERE CONSISTENT WITH EARLY LOOSENING. "

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9416496 ↗
• InjuryAug 14, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHELL LOOSENING. IT WAS REPORTED THERE WAS NO INGROWTH AT ALL ON THE SHELL. A 56MM TITANIUM HEMISPHERICAL SOLID BACK SHELL, LINER AND HEAD WERE REVISED TO A NEW STRYKER SHELL, LINER AND HEAD. NO ALLEGATIONS AGAINST THE LINER OR HEAD WERE REPORTED TO THE REP.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8893995 ↗
• InjuryJun 3, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ASEPTIC SHELL LOOSENING AND PAIN. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS REPORTED TO THE REP. THE SHELL, CERAMIC HEAD, AND POLY LINER WERE REVISED TO A MULTI-HOLE REVISION SHELL, MDM/ADM LINER CONSTRUCT, AND A CERAMIC HEAD WITH SLEEVE (THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR HEAD). REP PROVIDED A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8664571 ↗
• InjuryDec 11, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING OF THE SHELL. A STRYKER SHELL, LINER, AND HEAD WERE REVISED TO A TRITANIUM REVISION SHELL, ALL-POLY LINER, AND CERAMIC HEAD.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8152766 ↗