Trident 502-11-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540432056), received between Dec 10, 2018 and Jun 19, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2023Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING HAS BEEN REPORTED "CUP HAD BECOME LOOSE. REMOVED BY HAND."

  Patient problems: Inadequate Osseointegration

  MAUDE report 17151045 ↗
• InjuryFeb 9, 2021Malposition of Device; Malposition of Device

  AS REPORTED: "CHRONIC DISLOCATING TOTAL LEFT HIP." A FEMORAL HEAD, POLY LINER, SHELL AND SCREW WERE REVISED. SPOKE TO REP. THE SURGEON WAS UNHAPPY WITH THE IN SITU SHELL'S POSITION AND WANTED TO CHANGE ITS VERSION.

  Patient problems: Joint Dislocation

  MAUDE report 11300594 ↗
• InjuryMay 19, 2020Loss of Osseointegration; Loss of Osseointegration

  EXTRACTION WAS PERFORMED BECAUSE OF SUSPECTED THA INFECTION. WHEN PATHOLOGICAL CONFIRMATION WAS PERFORMED DURING THE OPERATION, THERE WAS NO INFECTION AND IT WAS STERILE LOOSENING. WHEN I TRIED TO DISLOCATE THE CUP / HEAD BEFORE REMOVING IT, THE CUP / HEAD WAS STUCK AND COULD NOT BE REMOVED. PLEASE INVESTIGATE WHETHER IT IS DUE TO A PRODUCT ERROR OR A CHANGE IN THE PHYSICAL PROPERTIES OF THE X3 INSERT. (B)(6) 2019 PICTURES IMMEDIATELY AFTER THE FIRST THA OPERATION (POSITION OF CUP SCREW) AND (B)(6) 2020 (POSITION OF CUP SCREW) ARE CLEARLY CONVOLUTED. UPDATE: "1. IT WAS NOTED THE CUP AND THE HEAD GOT STUCK." UPDATE: "1. IT WAS NOTED THE CUP SIDE HAS LOOSENED. PLEASE CHECK THE X-RAY IMAGES AFTER SURGERY AND BEFORE REMOVAL. THE CUP HAS ROTATED MORE THAN 90 DEGREES (FROM THE SCREW POSITION). 2. DUE TO THE DIFFICULTY IN DISLOCATING THE PATIENT: PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE (OR INDICATE ¿NONE¿ TO CONFIRM THERE WAS ABSOLUTELY NO DELAY): THERE WAS NO DELAY IN THIS SURGERY. 3. WHICH DEVICE(S) WHICH WERE REVISED ARE RIDENTCUP 56MM, 36MM INNER DIAMETER X3 INSERT, 2X 20MM SCREW, ACCOLADE 127 DEGREE # 5, 36MM DELTA HEAD. 4. THE SURGICAL PROCEDURE COMPLETED SUCCESSF

  Patient problems: Injury

  MAUDE report 10071343 ↗
• InjuryApr 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH DISLOCATED LEFT TOTAL HIP REPLACEMENT (EXETER, TRIDENT WITH MDM) FOLLOWING FALL DOWN STAIRS. HIP COULD NOT BE REDUCED AS A CLOSED REDUCTION. WHEN HIP JOINT WAS OPENED, SURROUNDING TISSUES WAS A GREY/BLACK COLOUR CONSISTENT WITH METALOSIS. 28MM LFIT HEAD HAD DISASSOCIATED FROM MDM HEAD. WHEN MDM LINER WAS REMOVED A SMALL METAL FRAGMENT WAS PRESENT IN THE JOINT. THIS FRAGMENT HAD NUMBERS ON IT CONSISTENT WITH THE LOT NUMBER FOR IMPLANTED TRIDENT HEMISPHERICAL SHELL. TRIDENT SHELL WAS EXPLANTED WHICH REVEALED WHERE METAL FRAGMENT HAD COME FROM. ACETABULUM WAS REAMED. A TRITANIUM MULTIHOLE CUP WAS IMPLANTED WITH MDM LINER AND HEAD.

  Patient problems: Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 9964295 ↗
• InjuryDec 10, 2018Unstable; Unstable

  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. IT IS FURTHER ALLEGED THAT HE "BEGAN TO EXPERIENCE PROGRESSIVE PAIN; A GRINDING OR CLUCKING SENSATION IN HIS RIGHT LEG; LOSS OF MOBILITY; INFLAMMATION AND SORENESS AROUND THE IMPLANT; POPPING NOISE FROM RIGHT HIP; EXTREME PAIN AND INSTABILITY OF RIGHT LEG; METALLOSIS AND SEVERE DISCOMFORT." ON OR ABOUT (B)(6) 2017 HE UNDERWENT REVISION SURGERY OF HIS RIGHT HIP.

  Patient problems: Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 8148605 ↗