Trident 690-00-32HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327025569), received between Sep 28, 2018 and Jul 26, 2024 — classified as 4 injuries, 1 malfunction.

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

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY LEFT THA OUT OF CORS SCOPE. ON (B)(6) 2022, THE PATIENT HAS A PERIPROSTHETIC JOINT INFECTION AND IS ENTERED INTO CORS WITH A PROXIMAL FEMORAL REPLACEMENT. THE PATIENT DEVELOPED AGAIN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ONLY THE MDM & HEAD COMPONENTS EXCHANGED ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT DEVELOPS PJI AGAIN AND A REVISION IS PERFORMED, WITH CONSTRAINED LINER, HEAD (AND TAPER SLEEVE), AND PROXIMAL GMRS COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 19838979 ↗
• InjuryMay 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CONSTRAINED LINER DISLOCATION TYPE III OR IV ON (B)(6). REVISION DONE (B)(6). SWITCHED OUT FOR MODULAR DUAL MOBILITY.

  Patient problems: Joint Dislocation

  MAUDE report 14350120 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. EXAMINATION NOTES PROVIDED BY THE REP INDICATE THE FOLLOWING: "EXCRUCIATING PAIN IN THE HIP REGION WHEN HE TRIES TO STAND FROM A SEATED POSITION AND PARTICULARLY WHEN HE TRIES TO GET IN AND OUT OF A CAR¿BEGAN EXPERIENCING PAIN IN THE LEFT FOOT...I THINK HE IS DEVELOPING IMPINGEMENT CREATING A POLYETHYLENE SYNOVITIS..." A 32 +0 BIOLOX C-TAPER HEAD AND SLEEVE, AND SIZE H TRIDENT CONSTRAINED LINER WERE REVISED TO A 28 +0 BIOLOX C-TAPER HEAD AND 28MM SIZE H CONSTRAINED LINER. REP PROVIDED OPERATIVE REPORTS, USAGE SHEETS, EXAM NOTES, AND AN MRI REPORT AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Arthritis; Injury; Pain

  MAUDE report 9335713 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE COURSE OF A TOTAL HIP REIMPLANT PROCEDURE, DR (B)(6) CHOSE TO IMPLANT A CONSTRAINED ACETABULAR INSERT. DURING THE TRIAL RANGE OF MOTION EXERCISE, THE CONSTRAINED LINER DISASSOCIATED. THE METAL BIPOLAR PORTION CAME APART FROM THE POLY INSERT WHICH REMAINED FIRMLY IN THE SHELL. A SECOND IDENTICAL COMPONENT WAS THEN IMPLANTED UNEVENTFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086742 ↗
• InjurySep 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7919443 ↗