Trident 502-01-52ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613153073086), received between Apr 19, 2017 and Jul 18, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD TOTAL HIP 13 YEARS AGO AND RECENTLY STARTED TO EXPERIENCE PAIN IN HER HIP. UPDATE AS PER MED REVIEW COMMENT: "THE X-RAY SHOWS DISSOCIATION OF THE FEMORAL HEAD WITH DEFORMATION OF THE TRUNNION. THE CUP HAS LOST FIXATION AND IS NOW ORIENTED VERTICALLY. "

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15040302 ↗
• InjuryDec 30, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAVING RIGHT HIP PAIN. DOCTOR DIAGNOSED ON X-RAY. PAINFUL LOOSE ACETABULAR COMPONENT.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9532014 ↗
• InjuryMay 28, 2019Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING REVISION EVENT WAS INCLUDED IN A REPORT RECEIVED AS PART OF THE (B)(6) IIS: PATIENT HAD A RIGHT PRIMARY THA DUE TO OSTEOARTHRITIS; UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT WHERE THE CUP, HEAD AND LINER WERE EXCHANGED. PATIENT'S BMI IS REPORTED AS 38.1.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8645401 ↗
• InjuryMay 28, 2019Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING REVISION EVENT WAS INCLUDED IN A REPORT RECEIVED AS PART OF THE (B)(6) IIS: PATIENT HAD A RIGHT PRIMARY THA DUE TO OSTEONECROSIS; UNDERWENT REVISION FOR ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT - ACETABULAR COMPONENT REVISED. THE PATIENT'S BMI IS REPORTED AS 23.6.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8645374 ↗
• InjuryFeb 18, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION, SUBLUXATION AND CUP IMPINGEMENT. INTRA-OPERATIVELY, IT WAS OBSERVED THAT THE SHELL WAS WELL-FIXED BUT MALPOSITIONED, THE LIP OF THE LINER WAS FOUND TO BE GROOVED, WORN, AND CRACKED, AND MILD WEAR DEBRIS WAS FOUND IN THE HEAD-TRUNNION INTERFACE. A TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL, 10° E TRIDENT LINER, AND 36 +5 V40 LFIT HEAD WERE REVISED TO A TRITANIUM REVISION SHELL WITH 4 SCREWS, A 40 LINER, AND A 40 METAL HEAD. THE ACCOLADE I STEM WAS WELL-FIXED WITH THE TRUNNION IN GOOD CONDITION AND WAS NOT REVISED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8347692 ↗
• InjuryJun 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. IT IS FURTHER ALLEGED THAT THE PATIENT BEGAN EXPERIENCING RIGHT HIP PAIN AND WAS USING A WALKER FOR AMBULATION. X-RAYS TAKEN IN 2016 "REVEALED A BROKEN SCREW WITHIN THE ACETABULAR COMPONENT AND MEDIAL MIGRATION OF THE ACETABULAR COMPONENT CAUSING PROTRUSION". THE PATIENT THEN UNDERWENT REVISION SURGERY OF THE RIGHT HIP ACETABULAR COMPONENT ON (B)(6) 2017.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7635447 ↗
• InjuryMar 13, 2018Loss of Osseointegration; Loss of Osseointegration

  SURGEON STATED HE HAD A PATIENT WITH A LOOSENED TRIDENT HIP CUP FROM (B)(6) 2017. PATIENT HAS BEEN REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7335913 ↗
• InjuryApr 19, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION.

  Patient problems: Injury; Joint Dislocation; No Code Available

  MAUDE report 6504508 ↗