Trident 500-11-52ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540431868), received between Jan 5, 2017 and Jun 9, 2025 — classified as 4 injuries, 1 malfunction.

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. 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.

• InjuryJun 9, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. THE PATIENT HAD FALLEN 8 MONTHS PRIOR TO REVISION AND SUSTAINED AN ACETABULAR FRACTURE. NON-OPERATIVE TREATMENT FAILED, AND THE SHELL LOOSENED. ONCE THE PATIENT WAS OPEN, SURGEON NOTED BLACK TISSUE INSIDE THE PATIENT. AFTER REMOVING THE HEAD FROM THE STEM, BLACK MATERIAL WAS SEEN INSIDE THE HEAD AND MODERATE TRUNNION WEAR WAS NOTED. THE PATIENT'S HIP CONSTRUCT WAS REVISED TO A COMPETITOR HIP. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CONFIRMED THERE WAS NO HEAD DISSOCIATION.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 22165322 ↗
• InjuryFeb 23, 2025Corroded; Degraded; Corroded; Degraded

  THE FOLLOWING WAS REPORTED: "I HAVE AN EXPLANTED MDM FROM A PATIENT. THE OPERATING SURGEON WHO REVISED IT HAS REQUESTED IT BE SENT BACK TO STRYKER FOR INVESTIGATION. " UPDATE: PATIENT HAD PAIN AND SWELLING AT HIP - PSEUDO TUMOUR COLLECTION OF FLUID. REASON FOR REVISION: PAIN AND SWELLING SECONDARY TO ARMD. DURING THE REVISION, CORROSION AT INTERFACE BETWEEN DM LINER AND THE SHELL WAS NOTICED. SHELL, LINER AND HEAD WERE REVISED. THE STEM REMAINED IMPLANTED.

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 21442661 ↗
• InjuryJun 10, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PATIENT REPORTS PAIN AFTER THR LEFT (THR ON 03-NOV-2017). CUP REVISION DONE ON (B)(6) 2019. PATIENT ALSO INCLUDED IN THE HS038 ATX STUDY FOR RIGHT THR. REVISION NOTED IN SOURCE DOCUMENTATION DURING ROUTINE MONITORING FOR THE ATX STUDY. PATIENT REPORTED PAIN. PAIN RESOLVED AFTER CUP REVISION.

  Patient problems: Pain

  MAUDE report 14653206 ↗
• InjuryAug 4, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  WHEN TRAILING DURING AN EXETER TRIDENT MDM PROCEDURE THE TRIDENT SHELL SPUN OUT WHILE PUTTING THE LEG THROUGH A RANGE OF MOTION. THE SURGEON THEN DECIDED TO IMPLANT A 50MM RIMFIT CUP. THE SURGEON STATED THAT HE DIDN'T THINK THE TRIDENT THAT HE HAD REMOVED WAS AS ROUGH AS HE USUALLY EXPECTS. THE IMPLANT WAS LOOSE ON TRAILING.

  Patient problems: Injury; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10362251 ↗
• MalfunctionJan 5, 2017Positioning Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  PROBLEM OCCURED WHEN UNABLE TO SEAT ACETABULUM COMPONENT. SURGERY WAS A BILATERAL THR (PROBLEM OCCURRED WHEN REPLACING RIGHT HIP). ON (B)(6) 2016: THE SURGEON WAS UNABLE TO SEAT THE CUP DUE TO THE FACT THAT HE COULD NOT REMOVE THE IMPACTOR BOLT FROM THE CUP "AS STATED BY STUDY COORDINATOR, CUP SCREWED TOO TIGHTLY ONTO THE INSERTER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6225636 ↗