Trident II 702-04-60G (UDI 07613327343908)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327343908), received between Oct 30, 2019 and Nov 15, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED - THE PATIENT PRESENTED TO THE SURGEON WITH HIP PAIN AND SWELLING AND THE SURGEON THEN DECIDED THE PATIENT REQUIRED A WASH OUT AND EXAMINATION UNDER ANAESTHETIC IN THEATRE. ON EXPLANTATION, SEVERAL MARKS WERE OBSERVED ON THE X3 INSERT. ON DISLOCATION OF THE IMPLANTED PRIMARY HIP, THE SURGEON NOTICED SEVERAL LINEAR MARKS ON THE FLOOR OF THE X3 INSERT AND ON REMOVAL IT WAS NOTICED THAT THERE WAS A LINEAR MARK ON THE BIOLOX HEAD. THE SURGEON DECIDED THAT THE SHELL NEEDED TO BE REPLACED, SO THE SHELL IN SITU WAS EXPLANTED AND REPLACED WITH A TRIDENT 2 REVISION SHELL AND TWO SCREWS. THE LINER WAS REPLACED AS WAS THE 36MM BIOLOX HEAD.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20695729 ↗
• InjuryNov 7, 2024Loss of Osseointegration; Loss of Osseointegration

  CUP CAME LOOSE FROM ORIGINAL TOTAL HIP SURGERY DONE ON (B)(6) 2021. REVISION OF CUP, HEAD & SLEEVE, AND LINER DONE ON (B)(6) 2024.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20635732 ↗
• InjuryDec 15, 2023Osseointegration Problem; Osseointegration Problem

  REVISED A RIGHT HIP CUP, LINER AND HEAD DUE TO CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18340962 ↗
• InjuryJul 27, 2022Positioning Problem; Positioning Problem

  PATIENT RETURNED TO THEATRE FOLLOWING PRIMARY HIP JOINT REPLACEMENT DUE TO HEAD DISLOCATED OUT OF LINER (SAME DAY). CUP REPOSITIONED, 10 DEG LINER EXCHANGED FOR MDM, HEAD REVISED TO ORTHINOX HEAD AND ACCOLADE II STEM REMAINED.

  Patient problems: Joint Dislocation

  MAUDE report 15109731 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SURGEON CONTACT ME REPORTING SUSPECTED METALOSIS AND SOFT TISSUE ABNORMALITY." PATIENT WAS REVISED.

  Patient problems: Foreign Body Reaction

  MAUDE report 12325208 ↗
• InjuryOct 30, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISASSOCIATION OF THE 28 +4 LFIT HEAD FROM THE ADM POLY INSERT. PATIENT REPORTED HE HAD SLIPPED AND CAUGHT HIMSELF ON A RAILING WITHOUT FULLY FALLING. THE SURGEON WAS NOT CERTAIN IF THE DISASSOCIATION CAUSED THE SLIP OR VICE VERSA. AFTER A FAILED CLOSED REDUCTION OF THE PATIENT'S HIP, THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED FOR DEVICES OF THE SAME CATALOG NUMBERS, WITH THE EXCEPTION OF A 20 MM SCREW BEING REVISED TO TWO 25 MM SCREWS AS THE SURGEON WAS NOT SURE IF THE SHELL WAS TOO VERTICAL. THE STEM WAS REVISED SOLELY TO GAIN ACCESS TO THE SHELL, THERE ARE NO ALLEGATIONS AGAINST ANY OF THE OTHER REVISED DEVICES. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. THE REP REPORTED HE MAY BE ABLE TO GET PRE-REVISION X-RAYS AND POSSIBLY THE PRIMARY OPERATIVE REPORT, AND CONFIRMED THAT NO OTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9255416 ↗