Trident 623-10-32FRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327039863), received between Aug 18, 2017 and Mar 2, 2021 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  REVISION OF LOOSE TRIDENT SOLID BACK CUP. POST OP DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 11402376 ↗
• InjuryAug 20, 2020Fracture; Fracture

  HE HAD A CEMENT MANTLE FRACTURE PROXIMAL RIGHT HIP. HAD A TRAUMATIC FALL (B)(6) 2019 - LOOSE, OTHER HIP REQUIRED DHS (NON-STRYKER PRODUCTS INVOLVED ON OPPOSITE HIP). PROXIMAL FEMORAL OSTEOLYSIS. NOTICED ON X-RAY UPON NOTICING PAIN AND AFTER THEIR TRAUMA. UPDATE: 27 JULY 2019: SURGEON WAS REVISING DUE TO SIGNS OF OSTEOLYSIS. NOTICED CEMENT MANTLE FRACTURE DURING PROCEDURE.

  Patient problems: Injury

  MAUDE report 10434934 ↗
• InjuryMay 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CUSTOMER REPORTED THAT A PATIENT WHO UNDERWENT A HYBRID TOTAL HIP REPLACEMENT, PRESENTED WITH PAIN A FEW DAYS LATER. FOLLOWING X-RAYS, THE PHYSICIAN ALLEGED THAT THE LINER DISENGAGED OUT OF PLACE AND DECIDED TO CHANGE IT. FROM HOSPITAL'S INTERNAL INVESTIGATION, THEY SUGGESTED THAT THE LINER SHOWED A CRACK THROUGH THE LINER ITSELF AND ALSO DAMAGED ABOUT THE TOP (THEY REMARKED WHETHER THIS WAS DUE TO THE LINER BECOMING DISENGAGED?). HOSPITAL IS QUERYING WHETHER SIMILAR EVENTS HAVE BEEN REPORTED PREVIOUSLY. UPDATE 05/12/2020: "PLEASE CLARIFY WHAT HYBRID TOTAL HIP REPLACEMENT MEANS IN THIS CASE. UNCEMENTED CUP AND CEMENTED STEM. PLEASE PROVIDE THE CATALOG NUMBER AND LOT CODE FOR THE ACETABULAR SHELL. REF: 542-11-54F LOT: LT0E3V. IS ¿ABOUT THE TOP¿ REFERRING TO THE DOME OR THE RIM OF THE LINER. THE RIM OF THE LINER".

  Patient problems: Injury; Pain

  MAUDE report 10092692 ↗
• InjuryMar 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN EXETER / TRIDENT HIP WAS REVISED FOR RECURRENT DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9884709 ↗
• MalfunctionJun 27, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE DOCTOR USED THE 542-11-54F ACETABULAR PROSTHESIS IN HIP REPLACEMENT SURGERY. WHEN INSTALLING THE ACETABULAR LINING 623-10-32F, IT BECAME LOOSE AND DID NOT MATCH THE ACETABULAR CUP AND COULD NOT BE USED NORMALLY. AFTER REPLACING THE LINING WITH 623-10-28F AND MATCHING THE SIZE OF THE ACETABULAR PROSTHESIS, IT COULD BE NORMALLY INSTALLED AND USED, AND FINALLY THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739102 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT TOTAL HIP REPLACEMENT WASHOUT & IMPLANT EXCHANGE FOR INFECTION. ORIGINAL THR: (B)(6) 2019. TISSUE SPECIMENS SENT TO PATHOLOGY FOR ANALYSIS AT TIME OF SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8480447 ↗
• MalfunctionNov 8, 2018Packaging Problem; Physical Resistance/Sticking; Packaging Problem; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE SURGEON, (B)(6), WAS UNDERTAKING A HIP PROCEDURE AND ON OPENING THE PACKAGE FOR THE TRIDENT LINER NOTICED THAT THERE WAS A STICKY RESIDUE ON THE PACKAGE BETWEEN THE PAPER LAYER AND THE PLASTIC OUTER PACKAGING. THE IMPLANT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050799 ↗
• InjuryAug 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE PATIENT HAS DEVELOPED INFECTION FOLLOWING IMPLANTATION IN (B)(6) 2018 WITH STRYKER DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 7739711 ↗
• MalfunctionApr 23, 2018Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED THAT 2 DEVICES WERE OPENED AND THEY WERE NOT CLEAN INSIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450801 ↗
• MalfunctionApr 23, 2018Packaging Problem; Packaging Problem

  THE CUSTOMER REPORTED THAT TWO DEVICES WERE OPENED AND THEY WERE NOT CLEAN INSIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450491 ↗
• InjuryAug 18, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT SAT DOWN FROM STANDING AND EXPERIENCED A SUDDEN POP SENSATION IN ANTERIOR GROIN. A CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2017 FOR DISLOCATION OF RIGHT HIP. A HIP X-RAY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 6805861 ↗