Trident 623-00-32ERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327039450), received between Jan 5, 2018 and Aug 26, 2024 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY STRYKER SALES REP THAT PATIENT IS REQUIRED FOR REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20063109 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT HIP DISCOMFORT AND WANTS TO KNOW IF PARTS ARE SUBJECT TO A RECALL.

  Patient problems: Discomfort

  MAUDE report 18729726 ↗
• InjuryNov 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE WAS NO EXPLANATION PROVIDED. THE PATIENT SELECTED 'NO' FOR SATISFACTION. A FOLLOW-UP QUESTIONNAIRE WAS COMPLETED BY THE SUBJECT WHERE THEY ANSWERED "NO" FOR SATISFACTION WITH THE RESULTS OF THE STUDY HIP REPLACEMENT. THE SUBJECT REPLIED THAT THEY ARE NOT SATISFIED WITH THEIR RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15804739 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT FIVE YEARS POSTOPERATIVE, THE SUBJECT REPORTED VERY GOOD HEALTH AND MODERATE PAIN OR DISCOMFORT IN THE STUDY HIP. AT THIS POINT, HE ANSWERED ¿NO¿ TO BEING SATISFIED WITH HIS STUDY HIP REPLACEMENT. THE STUDY COORDINATOR BELIEVES IT IS POSSIBLE THE SUBJECT MARKED "NO" IN ERROR AS THE QUESTIONNAIRES WERE COMPLETED VIA MAIL AND THE SUBJECT NEVER EXPRESSED ANY DISSATISFACTION WITH HIS HIP REPLACEMENT. AT SIX YEARS POSTOPERATIVE, THE SUBJECT ANSWERED ¿YES¿ TO BEING SATISFIED WITH HIS STUDY HIP REPLACEMENT ON PATIENT QUESTIONNAIRES.

  Patient problems: Discomfort; Pain

  MAUDE report 14844872 ↗
• MalfunctionJan 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE 32 SIZE E WOULD NOT SEAT IN THE 54 SIZE E TRIDENT II SOLID SHELL AFTER MULTIPLE ATTEMPTS. 36 SIZE E IMPACTED ON FIRST ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113647 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: PATIENT UNDERWENT INDEX THA ON (B)(6) 2015. THEN THE PATIENT HAD A PERIPROSTHETIC JOINT INFECTION, SO ALL COMPONENTS WHERE REMOVED ON (B)(6) 2019. THE PATIENT WAS PLACED ON A SPACER. THEN THE PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2019, WITH OFF-LABEL USE IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 11107761 ↗
• InjuryOct 21, 2019Unstable; 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE 20/SEPTEMBER/2019: INFORMATION RECEIVED FROM STUDY SITE STATES "AFTER THE HIP REPLACEMENT, PATIENT PRESENTED WITH INSTABILITY FAILURE, THEN UNDERWENT REVISION WITH REMAINING CUP, OTHER COMPONENTS EXCHANGED (B)(6) 2018."

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9216229 ↗
• InjuryMay 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE RIGHT HIP. IT WAS REPORTED THAT THE PATIENT HAD BILATERAL HIP REVISIONS DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED). REP CAN PROVIDE PRE-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8645729 ↗
• InjuryDec 28, 2018Material Discolored; Material Discolored

  IT WAS REPORTED THAT THA WAS DONE WITH TRIDENT HA SHELL AND X3 LINER AND STEM. THE SHELL WAS DISLOCATED IN ABOUT ONE YEAR AFTER THA. THEREFORE, ALL DEVICES WERE REMOVED AND REVISION SURGERY WAS DONE. THE REMOVED POLYETHYLENE LINER WAS YELLOWISH DISCOLORED. UPDATE DEC 17, 2018- CAUSE OF REVISION SHELL WAS DISLOCATED (MALPOSITION).

  Patient problems: Injury

  MAUDE report 8204034 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP REPLACEMENT (B)(6) 2018. PATIENT RETURNED FOR INFECTED RIGHT TOTAL HIP REPLACEMENT REVISION. REIMPLANTATION OF IMPLANTS OCCURRED (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7969682 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WITH PRIMARY THA ON (B)(6) 2014 BY DR. (B)(6), PATIENT DEVELOPED PJI AND REQUIRED RESECTION ARTHROPLASTY (1ST. STAGE) (ALL COMPONENTS EXCHANGED) BY DR. (B)(6) ON (B)(6) 2017. SECOND STAGE REIMPLANTATION WAS PERFORMED IN (B)(6) 2018 (OFF-LABEL) BY DR. (B)(6).

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7674376 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A WASH OUT OF RIGHT HIP AND THE HEAD AND LINER WERE REPLACED. REP HAS CONFIRMED THERE WAS NO INFECTION PRESENT. NO REASON FOR REVISION WAS GIVEN. HE HAS STATED NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 7641217 ↗
• InjuryApr 2, 2018Unstable; Unstable

  REVISION DUE TO UNSTABLE LEFT HIP. IMPLANTED MDM LINER AND NEW FEMORAL HEAD".

  Patient problems: Injury

  MAUDE report 7390223 ↗
• InjuryJan 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 7167957 ↗