Trident II 7030-6530Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327345063), received between Jan 10, 2018 and May 9, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Fracture; Fracture

  SURGEON STATED THAT THE SCREW HEAD SPLIT IN HALF BEFORE FULL SEATING. RESULTED IN HAVING TO USE A METAL CUTTING BURR TO FLATTEN DOWN HEAD IN ORDER TO INSERT THE LINER. ADDITIONAL INFO.: 4/30/2024 - LEFT OR RIGHT SIDE: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282660 ↗
• InjuryAug 12, 2021Fracture; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "REVISED HIP FOR LOOSE CUP. PATIENT CAME WITH LOOSE CUP AND PAIN." PATIENT'S LEFT HIP WAS REVISED. A SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND 2 SCREWS WERE REVISED. REP PROVIDED AN OPERATIVE REPORT FROM THE PRIOR IMPLANTATION AND AN X-RAY. UPDATE 20/JULY/2021 WG: SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED MDM METAL LINER OR ADM/ MDM POLY INSERT. THE SHELL HAD SHIFTED THROUGH THE PATIENT'S PELVIS. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12311974 ↗
• MalfunctionDec 11, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE SCREW PENETRATED THROUGH THE ACETABULAR SHELL DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10990221 ↗
• MalfunctionMay 23, 2019Malposition of Device; Malposition of Device

  SURGEON NOTIFIED REP THAT X-RAYS 1 WEEK POST OP SHOW A SCREW PASSED COMPLETELY THROUGH THE ACETABULAR SHELL IN THE PATIENT'S RIGHT 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: MEDICAL REVIEW CONFIRMED THE EVENT AND CONFIRMED MALPOSITION OF THE SCREW AS A ROOT CAUSE OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637436 ↗
• 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 8637434 ↗
• MalfunctionJan 10, 2018Break; Fracture; Break; Fracture

  ACETABULAR SCREW FRACTURE IDENTIFIED AT THE 2 WEEK FOLLOW UP VISIT IN DOCTOR'S OFFICE WHEN RADIOLOGY FILMS WERE OBTAINED. PATIENT HAD NO COMPLAINTS AND WAS THEREFORE PLACED ON 20% PARTIAL NON-WEIGHT BEARING RESTRICTIONS. HARDWARE EXAMINED AS STABLE AND WELL SEATED. SUBSEQUENT VISITS .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7179839 ↗