Trident II 7030-6540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327345117), received between May 25, 2021 and Sep 14, 2023 — classified as 1 injury, 2 malfunctions.

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

• InjurySep 14, 2023Migration; Migration

  AS REPORTED: "PLEASE FIND ATTACHED INFORMATION FROM INDEX AND REVISION SURGERIES OF A RIGHT TOTAL HIP. THE REVISION WAS SECONDARY TO DISLOCATION. IT WAS DISCOVERED THAT THE CERAMIC HEAD DISASSOCIATED FROM THE POLY INSERT. ALSO DISCOVERED WAS A CRACK IN THE ACETABULUM AND THE APPEARANCE THAT THE CUP HAD MOVED. IT WAS ALSO DETERMINED THAT THE STEM WAS LOOSE. ALL IMPLANTS WERE REMOVED. A MULTIHOLE CUP WAS IMPLANTED WITH MULTIPLE SCREWS AND AN MDM LINER. THE FEMUR WAS PREPARED FOR AN INSIGNIA STEM AND TRIALED. THE HIP REMAINED GROSSLY UNSTABLE SO IT WAS DECIDED TO LEAVE THE PATIENT WITH A GIRDLESTONE. THE PLAN BEING TO COME BACK AFTER THE CUP HAS HEALED AND PLACE A REST MOD WITH CONSTRAINED LINER. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Dislocation

  MAUDE report 17747462 ↗
• MalfunctionSep 8, 2022Fracture; Fracture

  TRIDENT II TRITANIUM CLUSTER CUP, INSERTING A 7030 6.5X40MM SCREW AND IT BROKE. WE USED ANOTHER SCREW. PER RESPONSE: "YES, APPROXIMATELY 30MM OF THE 40MM. LEFT IT IN AS IT WASN'T PROUD TO PREVENT LINER FROM SEATING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377932 ↗
• MalfunctionMay 25, 2021Fracture; Fracture

  A SCREW APPEARS BROKEN ON A POST OP X-RAY. NO DELAY WAS CAUSED TO SURGERY. SURGEON DID NOT NOTICE ANYTHING OUT OF THE ORDINARY WHILE DRILLING OR IMPLANTING. SURGEON DOES NOT FEEL ANYTHING SPECIAL NEEDS TO BE DONE BEYOND NORMAL PATIENT FOLLOW UP. SURGEON WOULD LIKE A FOLLOW UP REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876650 ↗