TRIDENT II 709-04-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327343977), received between Aug 12, 2021 and Apr 15, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 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.

• InjuryApr 15, 2025Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  DISLOCATION OF THE CUP AND SCREW BREAKAGE OCCURRED. REVISION SURGERY IS PLANNED ON (B)(6) 2025.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 21838662 ↗
• InjuryFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISED A RIGHT HIP LINER AND HEAD DUE TO THE MDM METAL LINER DISENGAGING FROM THE SHELL AND OVERALL INSTABILITY. HE TIGHTENED ONE OF THE ACETABULAR SCREWS A COUPLE OF TURNS AND RE-IMPLANTED A NEW MDM LINER AND WENT FROM A -4MM HEAD TO A +12MM HEAD.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21464480 ↗
• InjuryOct 9, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE FOLLOWING WAS REPORTED: "THE SCREW WENT PAST THE SCREW HOLE OF THE SHELL.". UPDATE: ON (B)(6) 2023 OLD HIP PROTHESIS CUP WAS TAKEN OUT AND WAS REPLACED WITH THE NEW CUP, GOOD FIT. SCREWS WAS PLACED WITH GOOD ATTACHMENT. THE PATIENTS REHABILITATION AND RECOVERY IS DELAYED AS THE CUP HAS FAILED AND HE HAS TO UNDERGO A NEW SURGERY. IN THE END OF JULY PATIENT UNDERWENT AN X-RAY DUE TO INCREASED PAIN IN THE HIP AND PATIENT CAN NO LONGER WALK OR MOVE AS USUAL BUT NO SUSPECT OF INFECTION OR TRAUMA. X-RAY SHOWED THE CUP HAS LOOSENED, LUXATED AND A FEW FRACTURED SCREWS. REVISION SURGERY HAS BEEN PERFORMED ON 14TH AUGUST. UPDATE AS PER MED REVIEW: "I CAN CONFIRM THE DISLOCATION, DISPLACEMENT OF THE CUP AND FRACTURE OF THE SCREWS SINCE I WAS ABLE TO SEE A CT IMAGE WITH THESE FINDINGS. I CAN CONFIRM THE REVISION SINCE I WAS ABLE TO REVIEW THE OPERATION REPORT.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 17893047 ↗
• InjurySep 5, 2022Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A REVISION OF UNKNOWN COMPONENTS IN THE PATIENT'S RIGHT HIP, THE SCREW WAS FOUND TO HAVE PASSED THROUGH THE SHELL. SURGEON PLANS TO REVISE THE PATIENT (B)(6) 2022 AS THE SHELL SPUN OUT. SURGEON IS AN EXPERIENCED (OVER 30 YEARS) IN HIP CASES. REP IS NOT AWARE IF THERE WAS ANYTHING UNUSUAL ABOUT THE IMPLANTATION OF THE SCREW (ANGLE, ETC.)

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15354379 ↗
• InjuryApr 20, 2022Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  AS REPORTED: "PATIENT WAS ENROLLED IN TRIDENT II REVISION OUTCOMES STUDY. PATIENT STATES THERE IS A LOT OF MUSCLE PAIN AROUND THE HIP AREA, USING A CANE TO WALK BUT IS LIMITED BY ANKLE PAIN AND SWELLING." CLINIC NOTES INDICATE: "LOOSENING OF HIP JOINT PROSTHESIS. MECHANICAL LOOSENING OF INTERNAL LEFT HIP PROSTHETIC JOINT. WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT".

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 14160659 ↗
• InjuryAug 12, 2021Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; 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 12311969 ↗