Trident 540-11-50ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540237828), received between Apr 11, 2018 and Feb 21, 2022 — 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 21, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. PER MEDICAL REVIEW: "CUP LOOSE GROSSLY, POLY SEVERELY DAMAGE."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13572059 ↗
• InjuryJun 2, 2020Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S HIP ON (B)(6) 2020. AS REPORTED: "THE PATIENT HAD HER PRIMARY HIP DONE IN 2012 IN NEW YORK. A CEMENT STEM WAS PLACED AND A 50 TRIDENT PSL CUP. PATIENT HAD RECURRENT DISLOCATIONS AND RECEIVED REVISION SURGERY ON (B)(6) 2020 . AT THAT TIME IT WAS FOUND THAT THE CUP WAS SOLID AND DIDN¿T NEED REMOVAL SO WE PLACED AN MDM LINER FOR THE E CUP WITH A 28 +8 METAL HEAD. FINAL XRAYS LOOKED GOOD BUT NOTED THE ORIGINAL CUP POSITION WAS VERTICAL. WE RECENTLY FOUND OUT THAT THE PATIENT WAS AGAIN DISLOCATED [WHILE TYING SHOE...HIP POPPED OUT]. THIS TIME, SHE DISSOCIATED THE SMALL HEAD FROM THE LARGE MDM HEAD. PLEASE NOTE THAT I WAS IN THE PREVIOUS SURGERY AND KNOW THAT THE HEAD CONSTRUCT WAS PROPERLY PUT TOGETHER. WE REMOVED THE HEAD AND LINER HEAD AND REMOVED THE PSL CUP. SHE THEN PLACED A 52 MULTIHOLE TRIDENT II CUP AND CONSTRAINED LINER."

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10108800 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT HIP REPLACEMENTS (B)(6) 2013. PATIENT RETURNED FOR REVISION BY ACETABULAR PERIPROSTHETIC FRACTURE (B2). OFF-LABEL REVISION (NOT REPORTED IN CORS). ALL COMPONENTS EXCHANGED EXCEPT FEMUR.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8352289 ↗
• InjuryJun 14, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENTS' RIGHT HIP WAS REVISED DUE TO PAIN, OSTEOLYSIS, AND ASEPTIC LOOSENING. INTRA-OPERATIVELY, SURGEON REPORTED THAT PATIENT HAD AN ACETABULAR DISCONTINUITY DUE TO A HEALED FRACTURE (REP REPORTED THAT NO PLATES OR SCREWS HAD BEEN USED TO ADDRESS THE FRACTURE). PATIENT WAS REVISED TO COMPETITOR SHELL AND LINER WITH A STRYKER UNIVERSAL TAPER BIOLOX HEAD.

  Patient problems: Inadequate Osseointegration; Injury; Osteolysis; Pain

  MAUDE report 7602932 ↗
• InjuryApr 11, 2018Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT REVISED FOR ACETABULAR LOOSENING FOLLOWING PRIMARY [RIGHT] THA. NO PRE-OPERATIVE REVISION RADIOGRAPHS AVAILABLE. ALL COMPONENTS EXCEPT THE STEM WERE REVISED".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7421279 ↗