Trident 509-02-62GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327025187), received between Aug 21, 2018 and Jun 30, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED ANTERIORLY (ON (B)(6)) FOLLOWING A REVISION HIP REPLACEMENT. REVISION WAS ON (B)(6) 2020, TO REMOVE A MITTLEMEIER TYPE SCREW IN CUP (SMITH & NEPHEW BRAND). THERE WAS A LOT OF OSTEOLYSIS BEHIND THE CUP & CUP WAS REVISED TO A TRITANIUM REVISION SHELL WITH MDM. ON STANDBY AT THIS REVISION ON (B)(6) WAS A SMITH AND NEPHEW CAGE AND A CONSTRAINED CEMENTED CUP (STRYKER). THE DOCTOR DECIDED NOT TO USE THE CAGE AND CONSTRAINED CUP, STATING THAT THE HIP FELT STABLE WITH THE TRITANIUM AND MDM CONSTRUCT. LATE ON THE NIGHT OF (B)(6), I RECEIVED A CALL TO SAY THAT PATIENT WAS DISLOCATING & THEY WERE GOING TO REVISE TO A CAGE. TRITANIUM CUP AND MDM WAS REMOVED; SMITH & NEPHEW CAGE PUT IN WITH A STRYKER ALL-POLY CONSTRAINED CUP. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR WANTED TO ¿ROUGH UP¿ THE BACK OF THE ALL POLY CONSTRAINED CUP, I TOLD HIM THIS WAS OFF-LABEL. THE DOCTOR USED THE BONE NIBBLERS ON THE BACK OF THE CUP; WHERE THE CEMENT INTERFACE WAS. PATIENT IS FEMALE, OVER 70 YEARS OLD, OPERATIVE SIDE IS RIGHT HIP.

  Patient problems: Injury

  MAUDE report 10210831 ↗
• InjuryJun 24, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO A LOOSE SHELL. THE TITANIUM REVISION SHELL, ALUMINA LINER, AND ALUMINA HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD. REGARDING A REVISION SHELL BEING IN SITU, REP REPORTED GIVEN THE FACTS THAT THE IMPLANTATION TOOK PLACE AT AN UNKNOWN DATE IN AN UNKNOWN FACILITY, THE PATIENT'S AGE, AND THE PATIENT'S EXISTING BONE QUALITY ISSUES, THE IMPLANTATION WAS LIKELY A PRIMARY SURGERY USING A REVISION SHELL FOR ITS LARGER SIZE TO ADDRESS THE PATIENT'S BONE QUALITY ISSUES. REP PROVIDED EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10189384 ↗
• InjuryJul 17, 2019Osseointegration Problem; Osseointegration Problem

  A 60MM TRITANIUM CUP REQUIRED REVISION FOR LOOSENING. THE SURGEON BELIEVED IT WAS NOT THE FAULT OF THE PROSTHESIS. 2ND REVISION OF ORIGINAL ZIMMER CUP. UPDATE: "THE SCREWS WERE ACCIDENTALLY DISCARDED AT LEAST ONE WAS BROKEN AS WELL."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8797745 ↗
• InjuryAug 21, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION OF ACETABULAR COMPONENT FOR ACETABULAR FRACTURE ACEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7802657 ↗