Trident 621-00-36GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327023671), received between Aug 31, 2018 and Apr 15, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE 18-MAR-2020: AS PER OPT REPORT: "THERE WAS SEVERE BURNISHING OF THE TRUNNION FROM IMPINGEMENT AND WEAR AGAINST THE ACETABULUM (LINER WEAR) AND LEFT DISSOCIATED FEMORAL HEAD IMPLANT." UPDATE 30/MARCH/2020 WG: AS STATED IN THE REVISION OPERATIVE REPORT IN ADDITION TO PREVIOUS UPDATE: "THE POLYETHYLENE INSERT WAS REMOVED. THE ACETABULAR SHELL COMPONENT WAS IN GOOD ALIGNMENT AND CONDITION." THE SHELL WAS NOT REVISED.

  Patient problems: Injury

  MAUDE report 9963937 ↗
• InjuryAug 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT COMPLAINED OF HIP PAIN. THE SURGEON REVISED THE HIP, REMOVING THE 36+5 LFIT HEAD AND REPLACED WITH A BIOLOX AND SLEEVE. THE SURGEON ALSO DEBRIDED SOFT TISSUES OF ANY DEBRIS ASSOCIATED WITH METAL FROM HEAD/TRUNNION JUNCTION. THE SURGEON ALSO CHANGED THE LINER AND REPLACED WITH AN X3 LINER. SOME SOFT TISSUE DAMAGE AND OSTEOLYSIS WAS ALSO NOTED.

  Patient problems: Injury; Osteolysis; Pain; Tissue Damage

  MAUDE report 7838600 ↗