ENDURANCE 1521-62-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295057338), received between Jan 3, 2018 and Feb 14, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 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.

• InjuryFeb 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT HAD A TOTAL LEFT HIP ARTHOPLASTY DONE (B)(6) 2021. ("TOTAL HIP PACKAGE LEFT FEMORAL STEM 12/14 TAPER ENDURANCE HIP SIZE 3 1521 62 000 DEPUY SNA"). THE CEMENT FELL OUT("2/3RDS OF IT FROM BOTTOM UP"). END OF STEM GOUGING 2 NOTCHES INSIDE FEMORAL. CHRONIC PAIN. RALLY MY AB CEMENT WAS USED. NOW THEY WANT TO DO IT ALL OVER AGAIN, WITH NO GUARANTEE IT WON'T HAPPEN AGAIN. SURGEON IS VERY VAGUE ON HIS PLAN OF ATTACK, WHEN ASKED IF HE IS GOING TO USE A PRESS IN STEM THIS TIME, OR CEMENTED.

  Patient problems: Limb Fracture; Pain

  MAUDE report 16370749 ↗
• InjuryJan 3, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4). LITIGATION ALLEGES THAT PATIENT EXPERIENCED HIP PAIN, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, IT IS ALLEGED THAT IMPLANT IS RELEASING METAL IONS INTO PATIENT'S BODY. DOI: UNKNOWN - DOR: NONE REPORTED (RIGHT SIDE). (B)(6). UPDATE DEC 05, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES INJURY AND LIMITED MOBILITY. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL AND ACETABULAR COMPONENT LOOSENING. REVISION NOTES REPORTED GROSSLY LOOSE FEMORAL COMPONENT. CLINICAL NOTES REPORTED OF LEG LENGTH DISCREPANCY, OSTEONECROSIS, ANTALGIC GAIT, DECREASED RANGE OF MOTION, BURSITIS AND TENDERNESS. LABORATORY RESULT FOR METAL IONS IS BELOW 7PPB. ADDED STEM, CUP AND CEMENT PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON: DECEMBER 22, 2017. DOI: (B)(6) 2007; DOR: (B)(6) 2014; RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7159911 ↗