Trident 540-11-58GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540237866), received between Sep 8, 2017 and Nov 27, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. AS PER MEDICAL REVIEW: "THE IMPLANT RECORD AND OPERATIVE REPORT CONFIRM A REVISION THA WAS PERFORMED FOR LOSS OF ACETABULAR FIXATION WITH CHANGE IN COMPONENT POSITION IN A CEMENTED THA. NO DOCUMENTATION WAS PROVIDED REGARDING INCREASED METAL ION LEVELS." MEDICAL RECORD: "[...] FOLLOWUP RADIOGRAPH OF THE HIP WAS OBTAINED AND THERE WAS OBVIOUS CHANGE IN POSITION OF THE ACETABULAR COMPONENT WITH LOSS OF FIXATION OF THE CEMENT. [...]".

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20799079 ↗
• InjuryDec 21, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE CUP MEDIALIZING IN THE PATIENT. A 58MM PSL SHELL, FEMORAL HEAD, AND LINER WERE REVISED TO A NEW SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation

  MAUDE report 11044236 ↗
• InjuryOct 6, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  REVISION SURGERY ON STRYKER IMPLANTS. REPLACED WITH STRYKER STEM AND FEMORAL HEAD AND DEPUY CUP AND INSERT (B)(6) 2020. PATIENT COMPLAINT OF PAIN AND SQUEAK / CLUNKINESS. SIGNS OF TRUNIONOSIS AND IMPINGEMENT NOTED BY SURGEON. STRIPE WEAR ON CERAMIC HEAD. LINER RIM DAMAGED BY WEAR FROM STEM. REVISION ON PREVIOUS PRIMARY SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Pain

  MAUDE report 10633671 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "SURGEON STATES PATIENT HAS OSTEOLYSIS IN ACETABULUM AND PROXIMAL FEMUR. PATIENT HAS CERAMIC ON CERAMIC CONSTRUCT IMPLANTED". SPOKE TO REP, WHO PROVIDED THE PRIMARY OPERATIVE AND IMPLANT REPORTS AND PRE-REVISION X-RAYS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Osteolysis

  MAUDE report 8752357 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON PERFORMED A REVISION OF PATIENT'S RIGHT HIP DUE TO INFECTION. REP REPORTED THAT CUP, BALL, AND LINER WERE REVISED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6853329 ↗