Trident 621-00-36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327038552), received between Aug 20, 2018 and Dec 23, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryDec 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS BOOKED FOR OPEN REDUCTION INTERNAL FIXATION AND REVISION OF FEMORAL PROSTHESIS FOLLOWING A PERIPROSTHETIC FEMUR FRACTURE. THE FRACTURE OCCURRED THE EVENING FOLLOWING HER TOTAL HIP AS SHE ATTEMPTED TO SIT WITH THE ASSISTANCE OF A NURSE. DURING THE REVISION PROCEDURE IT WAS NOTED THAT THE 36E CROSSFIRE INSERT WAS MOVING WITHIN THE 52 MM TRIDENT PSL SHELL. THE SURGEON ELECTED TO REMOVE THE INSERT AND REVISE IT TO ANOTHER 36E INSERT. PRIOR TO IMPLANTING THE NEW INSERT THE SURGEON INSPECTED THE TRIDENT SHELL AND NOTED NO IRREGULARITIES. HE THEN IMPACTED THE NEW LINER AND CONFIRMED IT WAS FULLY SEATED AND LOCKED IN THE SHELL.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 11063179 ↗
• InjuryAug 20, 2018Material Disintegration; Adverse Event Without Identified Device or Use Problem; Material Disintegration; Adverse Event Without Identified Device or Use Problem

  CONDITION AFTER IMPLANTATION OF AN ACCOLADE SHAFT WITH V40 HEAD, DEVELOPMENT OF A LARGE PSEUDOTUMOR IN THE GROIN AREA DUE TO KNOWN CONE PROBLEMS IN THIS IMPLANT COMBINATION. SURGEON FORWARDED US THE FOLLOWING INFORMATION: IN SUMMARY, THE INCIDENT IS THE FOLLOWING SITUATION: PATIENT (B)(6), (B)(6) YEARS, CURRENTLY 178 CM HEIGHT AND (B)(6) KG BODY WEIGHT. ANAMNESE: IN 2007 IMPLANTATION OF A CEMENTLESS HIP ENDOPROSTHESIS (ACCOLADE, TRIDENT, METAL HEAD -0.5, ARTICLE NUMBERS ACCORDING TO ATTACHED SURGICAL REPORT). DEVELOPMENT OF LOCAL METAL INTOLERANCE WITH LARGE "PSEUDOTUMOR" / ARMD IN THE LEFT HIP WITH COMPRESSION OF THE ILIAC VEIN PRESUMABLY IN THE YEARS 2014 TO 2107 OF INCREASING SIZE. CURRENTLY 2017/2018 INCREASING LOCAL DISCOMFORT IN THE LEFT HIP JOINT. METAL VALUE INCREASE WITH COBALT IN WHOLE BLOOD 6,89 UG / L (REFERENCE RANGE 0,5-3,9 UG / L) AT NORMAL CHROMIUM VALUES (0,62 UG / L AT REFERENCE VALUE 0,5 TO 4,0 UG / L IN WHOLE BLOOD ). X-RAY INCREASING OSTEOLYSIS IN THE CUP AREA, IN CT AND MRI, FORMATION OF A LARGE PSEUDOTUMOR BOTH IN THE AREA OF THE OUTSIDE HIP MUSCLES AND IN THE RETROPERITONEUM AROUND THE ILIACUS MUSCLE. DUE TO INCREASING COMPLAINTS, THE RESECTION OF THE PSEUDO

  Patient problems: Discomfort; Edema; Injury; Osteolysis; Reaction

  MAUDE report 7798976 ↗