TRIDENT II 709-04-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327343816), received between May 23, 2019 and Aug 25, 2022 — classified as 1 injury, 1 malfunction.

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

• InjuryAug 25, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A SHELL, 6 SCREWS, HEAD AND LINER WERE REVISED TO ANOTHER SHELL, LINER, SCREWS, AND HEAD.

  Patient problems: Joint Laxity

  MAUDE report 15293036 ↗
• MalfunctionMay 23, 2019Malposition of Device; Malposition of Device

  SURGEON NOTIFIED REP THAT X-RAYS 1 MONTH POST OP SHOW A SCREW PASSED COMPLETELY THROUGH THE ACETABULAR SHELL IN THE PATIENT'S LEFT HIP. IT IS NOT KNOWN AT THE TIME OF REPORT IF THE SCREW WAS IMPLANTED THAT WAY. THE SURGEON HAS NOT REPORTED A PLAN TO REVISE THE PATIENT AT THE TIME OF REPORT. UPDATE 20 MAY, 2019: MED REVIEW CONFIRMED THE EVENT AND ALSO IDENTIFIED SCREW AND SHELL MALPOSITION AND CONTRIBUTING FACTORS TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637345 ↗