Trident 542-11-46DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540240460), received between May 11, 2017 and Mar 12, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE CONSTRAINED ACETABULAR INSERT. AS THE PATIENT HAS HAD REPEATED REVISIONS FOR DISLOCATION, THE SURGEON DECIDED TO REVISE THE HEAD, LINER, SHELL, AND SCREWS IN ORDER TO RE-POSITION THE NEW SHELL.

  Patient problems: Joint Dislocation

  MAUDE report 11471805 ↗
• InjuryJun 4, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "LOOSENING OF ACETABULAR SHELL. REVISION RIGHT TOTAL HIP. REVISED ACETABULAR [COMPONENTS] AND FEMORAL HEAD ONLY". REP INDICATED THAT THE PATIENT WAS REVISED TO STRYKER AND COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8667844 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION 1 DONE ON (B)(6) 2017 DUE TO DISLOCATION AND PAIN. IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2016 AND AGAIN ON (B)(6) 2016 THE PATIENT WAS ADMITTED FOR DISLOCATIONS AND UNDERWENT CLOSED REDUCTIONS OF THE HIP. IT IS FURTHER ALLEGED ON (B)(6) 2017 LESS THAN TWO MONTHS AFTER THE LAST CLOSED REDUCTION SHE WAS BACK IN THE HOSPITAL BECAUSE OF A DISLOCATION AND PAIN. THE CUP AND LINER WERE REMOVED AND REPLACED.

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 8376067 ↗
• InjuryFeb 7, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT PRESENTED TO CLINIC WITH HIP PAIN. DOCTOR ORDERED CT SCAN AND CUP APPEARED TO BE LOOSE. CUP, DOME HOLE PLUG, SCREW, LINER, AND BIOLOX HEAD TAKEN OUT. REIMPLANTED TRIDENT II CUP.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8318989 ↗
• InjuryJan 23, 2019Mechanical Problem; Mechanical Problem

  PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT (B)(6) 2018. PATIENT TEMPLATED TO A 46MM CUP. DURING SURGERY IT WAS NOTED THAT THE FEMORAL HEAD MEASURED 40MM INDICATING THE MAGNIFICATION IN TEMPLATING WAS INACCURATE. THE SURGEON REAMED TO 46 MM WHICH WAS THE SMALLEST CUP AVAILABLE. HE IMPLANTED A 46 CUP AND HE GOT ONE SCREW IN THE DOME. AT THE TIME OF SURGERY HE WAS CONCERNED ABOUT FIXATION. HE KEPT THE PATIENT TOUCH DOWN WEIGHT BEARING. SHE ROLLED OVER IN BED AND DISLODGED HER CUP. SHE WAS SEEN IN THE ER AND SCHEDULED FOR SURGERY. SHE WAS REVISED TO A 42MM TRIDENT 2 MULTIHOLE CUP WITH 3 SCREWS. FIXATION APPEARED TO BE ADEQUATE AT THE TIME OF REVISION. THE PATIENT WAS STABLE THROUGH THE FULL RANGE OF MOTION. THE OPERATION WAS COMPLETED SUCCESSFULLY. SURGEON ALLEGES NO DEFECT WITH THE IMPLANTS AND SAID PATIENT FACTORS CONTRIBUTED TO THE FAILURE.

  Patient problems: Injury

  MAUDE report 8272584 ↗
• InjurySep 21, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LAWSUIT, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT BEGAN TO EXPERIENCE SOME DIFFICULTIES, REQUIRING A REVISION SURGERY ON (B)(6) 2008. UPDATE AS PER MEDICAL REVIEW: "ON (B)(6) 2008 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED WITH REMOVAL OF LOOSE, FRACTURED CERAMIC PIECES. EXTENSIVE METALLOSIS WAS NOTED AND A REVISION TOTAL HIP WAS PERFORMED FOR A DIAGNOSIS OF FRACTURED CERAMIC HEAD AND LINER, DISPLACED METAL LINER, EROSION SUPERIOR ACETABULAR SHELL, AND EXTENSIVE WEAR DEBRIS."

  Patient problems: Erosion; Inflammation; Injury; Reaction

  MAUDE report 7897741 ↗
• InjuryMay 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA E-MAIL FROM SALES REPRESENTATIVE THAT THE DR. SURGICALLY IMPLANTED AND DID A LEFT HIP REVISION DUE TO LOOSE CUP.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 6559883 ↗