Trident 509-02-60FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327025163), received between Mar 2, 2018 and Apr 8, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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.

• InjuryApr 8, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO THE SHELL BEING IN A VERTICAL POSITION. INTRA-OPERATIVELY, A SCREW WAS FOUND TO BE BROKEN. REP WAS NOT PRESENT IN THE OPERATING ROOM FOR REMOVAL OF THE ACETABULAR COMPONENTS AS THE PATIENT WAS BEING REVISED TO COMPETITOR ACETABULAR COMPONENTS AND DOES NOT KNOW WHICH SCREW WAS BROKEN. A SHELL, FOUR SCREWS, AND A FEMORAL HEAD WERE REVISED TO COMPETITOR ACETABULAR COMPONENTS WITH A BIOLOX HEAD AND SLEEVE. REP CONFIRMED THERE WERE NO ALLEGATIONS MADE AGAINST THE REVISED LINER AND HEAD, PROVIDED THE REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11633437 ↗
• InjuryApr 22, 2019Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  SURGEON REVISED A TOTAL HIP - THE LINER, HEAD AND SLEEVE FROM A 44 TO AN MDM DUE TO DISLOCATION. THE ORIGINAL SURGERY DATE WAS UNKNOWN; HOWEVER, A REVISION SURGERY WAS DONE ON (B)(6) 2011 TO ADDRESS A LOOSE CUP. UPDATE 26 MAR 2019: MEDICAL REVIEW INDICATES "THE X-RAY SUGGESTS THAT EXCESSIVE ACETABULAR COMPONENT VERSION IS PRESENT."

  Patient problems: Injury

  MAUDE report 8538087 ↗
• InjuryOct 2, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO IMPINGEMENT OF THE COMPETITOR STEM WITH THE STRYKER SHELL AND/ OR LINER. STRYKER DEVICES REVISED: A 60MM SHELL WITH 2 SCREWS AND A 44F POLY LINER REVISED TO A 62MM SHELL WITH 2 SCREWS AND A 40MM G POLY LINER.

  Patient problems: Injury

  MAUDE report 7927929 ↗
• InjuryApr 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT HAS LARGE ACETABULAR DEFECT DUE TO POOR BONE QUALITY. THE ACETABULAR CUP HAS MOVED AND IS NOT STABLE¿"

  Patient problems: Injury

  MAUDE report 7400853 ↗
• InjuryMar 2, 2018Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S HIP (SIDE NOT REPORTED) WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON REPORTED THAT THE SHELL WORE THROUGH THE MEDIAL WALL OF THE ACETABULUM AND WAS IN THE PATIENT THROUGH THE PELVIS. THE STRYKER SHELL, SCREWS, AND LINER WERE EXPLANTED. THE STEM WAS REPORTED AS A COMPETITOR STEM, HEAD OF UNKNOWN MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7309776 ↗