Trident 542-11-52ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327037197), received between Aug 11, 2017 and Feb 14, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2025Loss of Osseointegration; Malposition of Device; Migration; Loss of Osseointegration; Malposition of Device; Migration

  ADDITIONAL INFO. 22-MAY-2025: 1. LEFT HIP REVISION. 2. LOW ACTIVITY LEVEL. NORMAL DAILY WALKING IN HOUSEHOLD. 3. SURGEON REFUSED TO DISCLOSE OPERATIVE REPORTS FOR P&C REASON. BUT MENTIONED THAT PATIENT IS RECOVERING OK.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 21383526 ↗
• InjurySep 8, 2023Mechanical Problem; Mechanical Problem

  THE STEM NECK ON BOTH SIDES HAVE BEEN SHAVED OFF. FUTURE TREATMENT PLAN IS CURRENTLY UNDER CONSIDERATION. LEFT HIP. PATIENT HAD PAIN AND RESTRICTION OF ACTIVITIES. PER MEDICAL REVIEW: "... GIVEN THE POSITION OF THE ACETABULAR COMPONENTS THIS MAY WELL BE DUE TO IMPINGEMENT OF THE FEMORAL NECK ON THE ACETABULAR COMPONENT."

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17709492 ↗
• InjurySep 8, 2023Mechanical Problem; Mechanical Problem

  THE STEM NECK ON BOTH SIDES HAVE BEEN SHAVED OFF. FUTURE TREATMENT PLAN IS CURRENTLY UNDER CONSIDERATION. RIGHT HIP. PATIENT HAD PAIN AND RESTRICTION OF ACTIVITIES. PER MEDICAL REVIEW: "... GIVEN THE POSITION OF THE ACETABULAR COMPONENTS THIS MAY WELL BE DUE TO IMPINGEMENT OF THE FEMORAL NECK ON THE ACETABULAR COMPONENT."

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17709491 ↗
• InjuryApr 18, 2023Unstable; Unstable

  PATIENTS RIGHT HIP WAS REVISED TO A CONSTRAINED CUP DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 16759431 ↗
• InjuryMar 6, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY IN (B)(6) 2011 AN LFIT ANATOMIC V40 FEMORAL HEAD WAS IMPLANTED IN THE PATIENT'S RIGHT HIP AND THE PATIENT WAS REVISED ON (B)(6) 2021. STRYKER WAS MADE AWARE OF THIS EVENT VIA LEGAL COUNSEL. UPDATE AS PER MED REVIEW DATED 17 FEBRUARY 2023: [...] REVISION SURGERY FOR DISSOCIATION OF A COCR LFIT V40 HEAD FROM AN ACCOLADE TMZF STEM APPROXIMATELY 10 YEARS AFTER THE INDEX PROCEDURE [...]. [...] THE CUP WAS AT A HIGH ABDUCTION ANGLE OF HIGH 500 RANGE ON X-RAY [...]

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16492347 ↗
• InjuryDec 1, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "HAD PAIN IN RIGHT HIP. NO IMPLANTS OR PAPERWORK TO COME BACK. REMOVED HEAD, CUP, LINER."

  Patient problems: Pain

  MAUDE report 12914220 ↗
• InjuryMay 24, 2021Loss of Osseointegration; Loss of Osseointegration

  SURGEON NOTIFIED ON A CASE THAT POSSIBLY NEEDED A REVISION SURGERY. THE SURGERY WAS DONE A FEW YEARS BACK USING STRYKER IMPLANTS. THE REASON ON THE REVISION SURGERY NEEDED POSSIBLY DUE TO ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11872773 ↗
• InjurySep 2, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND LOOSENING OF THE ACETABULAR SHELL. THE SHELL, 2 SCREWS, LINER, AND FEMORAL HEAD WERE REVISED TO A NEW SHELL, MDM LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 10482169 ↗
• InjuryApr 1, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. PATIENT ALSO HAD ELEVATED ION LEVELS (SURGEON REPORTED HIGH ION LEVELS COULD HAVE BEEN THE RESULT OF THE PATIENT HAVING BILATERAL KNEE REPLACEMENTS AND BILATERAL HIP REPLACEMENTS). SURGEON NOTED THE CUP WAS MALPOSITIONED AT IMPLANTATION (70° INCLINATION), AND ALSO THAT THE FEMORAL AND ACETABULAR COMPONENTS WERE WELL-FIXED. INTRA-OPERATIVELY, SOME CORROSION WAS NOTED IN THE HEAD/ TRUNNION INTERFACE, BUT THERE WAS NO DISCOLORATION OF FLUID OR TISSUE NOTED. THE SHELL, LINER, AND HEAD WERE REVISED TO A TRIDENT II REVISION SHELL, POLY LINER, AND A CERAMIC FEMORAL HEAD WITH SLEEVE. REP CONFIRMED THERE WERE ABSOLUTELY NO ALLEGATIONS AGAINST THE LINER (WEAR, DISCOLORATION, ETC).

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8471914 ↗
• InjuryJan 30, 2019Degraded; Osseointegration Problem; Degraded; Osseointegration Problem

  PATIENT UNDERWENT A PROSTHETIC BILATERAL HIP SURGICAL PROCEDURE FOR A COXARTHROSIS ON (B)(6) 2012 WITH AN ABGII MOD. ON (B)(6) 2017, HE UNDERWENT A REVISION SURGERY OF THE RIGHT STEM DUE TO THE METALLOSIS. ON (B)(6) 2017, HE UNDERWENT A REVISION OF THE LEFT PROSTHESIS DUE TO THE MOBILIZATION OF THE ACETABULAR COMPONENT AND PERIPROSTHETIC CALCIFICATIONS OF THE LEFT HIP. THIS PI IS FOR REVISION OF THE LEFT HIP.

  Patient problems: Calcium Deposits/Calcification; Inadequate Osseointegration; Inflammation; Injury; Reaction

  MAUDE report 8291330 ↗
• InjuryJul 28, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO PAIN. THE SURGEON REPORTED HE FELT THE SHELL WAS LOOSE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7729521 ↗
• InjuryMay 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT FELL AND SUSTAINED AN ACETABULAR FRACTURE.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 7483820 ↗
• InjuryFeb 16, 2018Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO A GROSSLY LOOSE STEM AND RETROVERTED SHELL.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7276895 ↗
• MalfunctionFeb 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SURGEON WAS DISSATISFIED WITH THE FIXATION PROVIDED BY THE 542-11-52E AND REMOVED IT INTRA-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260899 ↗
• InjuryJan 5, 2018Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE SURGEON REPORTED THAT THE 30MM SCREW WAS BROKEN. PATIENT WAS REVISED TO AN MDM CONSTRUCT. A MEDICAL REVIEW BY CLINICAL CONSULTANT STATES "CUP MALPOSITION IN MEDIALIZED POSITION WITH ADDITIONAL ADVERSE SHORT LEG LENGTH EFFECTS HAS CONTRIBUTED TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY CONTRIBUTING TO CUP LOOSENING REQUIRING REVISION."

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Pain

  MAUDE report 7168720 ↗
• InjuryNov 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ACETABULAR CUP REVISION.

  Patient problems: Injury

  MAUDE report 6993666 ↗
• InjuryOct 25, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  AFTER A SURGERY PERFORMED ON (B)(6) 2017, WHICH WAS ABOUT A COMPLETE HIP PROSTHESIS THELIOS AND WHICH COMPLETED SUCCESSFULLY, THE PATIENT CAME BACK TO THE HOSPITAL IN EMERGENCY ONE MONTH LATER BECAUSE SHE HAD PAIN. IT APPEARED THAT THE PATIENT SUFFERS FROM A DISLOCATION: THE HEAD OF THE IMPLANT CAME OUT OF THE INSERT. THEN THE PATIENT WAS REVISED TO CHANGE THE IMPLANT ON (B)(6) 2017. A REVIEW BY A CLINICAL CONSULTANT NOTED UNKNOWN TRIDENT SHELL MALPOSITION AND INCOMPLETE SEATING OF AN MSM LINER IN THE TRIDENT SHELL AS BEING PROCEDURE-RELATED FACTORS CONTRIBUTING TO THE DISLOCATION EVENT.

  Patient problems: Injury; Pain

  MAUDE report 6977725 ↗
• InjuryAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  LINER CUP EXCHANGE DUE TO POSSIBLE INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6790513 ↗