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Trident X3 Insert 723-00-36DRecalls & reported problems

Howmedica Osteonics Corp. · Trident X3 0 Degree Polyethylene Insert · Class 2 · Implant

Quick summary

This Howmedica Trident X3 polyethylene insert is the plastic liner used inside a hip replacement. The 44 reports mostly describe patients having repeat surgery on the hip — often to clear an infection, and sometimes because the joint dislocated or felt unstable — with42 injuries and no deaths. No recalls name this device, and the number of reports is steady.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
45
Deaths reported
0
Injuries reported
43
Recalls naming it
0

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 07613327296990), received between Aug 12, 2021 and Aug 31, 2026 — classified as 43 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 3 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 2 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 2 reportsJul 2026: 1 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem32
  • Device Dislodged or Dislocated5
  • Degraded2
  • Device Difficult to Setup or Prepare2
  • Unstable2
  • Fracture1
  • Insufficient Device Problem Information1
  • Material Fragmentation1

Patient problems

  • Unspecified Infection28
  • Joint Dislocation5
  • Insufficient Information3
  • Bacterial Infection2
  • Joint Laxity2
  • No Clinical Signs, Symptoms or Conditions2
  • Pain2
  • Ambulation or Postural Difficulties1

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

    The following information was provided: Right hip. Patient complained of hip pain and infection symptoms post surgery. Removed the femoral head and liner and replaced the femoral head and liner.

    Patient problems: Unspecified Infection

    MAUDE report 50516664 ↗
  • InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

    Revised a right hip head and liner due to infection. A head and liner exchange was performed.

    Patient problems: Unspecified Infection

    MAUDE report 50105197 ↗
  • InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING EVENT WAS REPORTED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 25611890 ↗
  • InjuryJun 15, 2026Material Fragmentation

    PATIENT HAD A TOTAL HIP PROCEDURE COMPLETED WITH MAKO. AFTERWARD SURGERY PATIENT COMPLAINED OF PAIN, SO SURGEON REFERRED PATIENT TO DO A POSTOPERATIVE CT SCAN TO INVESTIGATE. UPON REVIEWING THE CT, SURGEON NOTICED A UNKNOWN DEBRIS WAS FOUND BETWEEN THE BIOLOX CERAMIC HEAD AND THE SHELL, ALTHOUGH SURGEON DOES NOT THINK THIS IS DIRECTLY CAUSE THE PAIN.

    Patient problems: Pain

    MAUDE report 25511436 ↗
  • InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A LEFT HIP DUE TO INFECTION. REMOVED ALL HARDWARE AND REPLACED WITH A SERF NOVAE STICK CUP AND COMPETITOR STEM.

    Patient problems: Unspecified Infection

    MAUDE report 25147107 ↗
  • InjuryMar 18, 2026Unstable

    THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. A HEAD AND 0° LINER WERE REVISED TO A NEW HEAD AND 0° CONSTRAINED LINER. NO OBSERVATIONS REPORTED ABOUT THE REVISED IMPLANTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Laxity

    MAUDE report 24630021 ↗
  • InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO POSSIBLE INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 24430745 ↗
  • InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO POSSIBLE INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 24430567 ↗
  • InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS PROVIDED: I&D ON THE LEFT HIP WITH HEAD/LINER EXCHANGE DUE TO PERSISTENT INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 24203056 ↗
  • InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF HEAD AND LINER DUE TO INFECTION. TOOK OUT 36D 0° LINER AND 36 -2.5 CERAMIC V40 HEAD. REPLACED WITH 36D 0° LINER, V40 TO C-TAPER SLEEVE, AND 36 -2.5 CERAMIC C-TAPER HEAD. LEFT HIP.

    Patient problems: Unspecified Infection

    MAUDE report 24198074 ↗
  • InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT LEFT HIP REVISED DUE TO POSSIBLE INFECTION. HEAD AND LINER EXCHANGED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

    Patient problems: Unspecified Infection

    MAUDE report 22951816 ↗
  • InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT'S RIGHT HIP REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. A HEAD AND LINER EXCHANGE WAS PERFORMED.

    Patient problems: Unspecified Infection

    MAUDE report 22635435 ↗
  • InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PERFORMED AN I&D WITH HEAD & LINER EXCHANGE OF A LEFT HIP DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 22584148 ↗
  • InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AS REPORTED: "LEFT HIP. RECURRENCE OF DISLOCATION. REVISED ALL COMPONENTS. SCREWS WERE RE-IMPLANTED IN NEW CUP. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A SIZE 3 INSIGNIA HIGH OFFSET STEM, 36 +2.5 CERAMIC HEAD, 36D 0° LINER, 50D CLUSTERHOLE SHELL AND SCREWS WERE REMOVED. A SIZE 4 INSIGNIA HIGH OFFSET STEM, 28 -4 CERAMIC HEAD, ADM/ MDM POLY INSERT, MDM METAL LINER, AND 52E CLUSTERHOLE SHELL WERE IMPLANTED, AND PREVIOUSLY REMOVED SCREWS WERE RE-IMPLANTED.

    Patient problems: Joint Dislocation

    MAUDE report 22305468 ↗
  • InjuryJun 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT LEFT HIP REVISED DUE TO ANTERIOR DISLOCATION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

    Patient problems: Joint Dislocation

    MAUDE report 22139538 ↗
  • InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PT HAD A HIP REPLACEMENT ON (B)(6) 2023 AND IS INQUIRING IF ANY OF THE IMPLANTS (ACCOLADE 2 HIP STEM AND FEMORAL HEAD BILEX DELTA) HAVE BEEN RECALLED. HIP FEELS WIRED LIKE ITS HITTING SOMETHING.

    Patient problems: Ambulation or Postural Difficulties

    MAUDE report 21859718 ↗
  • InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AS REPORTED: "REV LTHA- CUP REVISION FOR DISLOCATION. ORIGINAL WAS DONE IN DECEMBER AND SHE DISLOCATED ANTERIOR TWICE. HE REVISED THE CUP AND PUT IN MDM." SPOKE TO REP, THE HEAD CAME OUT OF THE LINER. BECAUSE THE HIP WAS A POSTERIOR APPROACH HIP AND THE PATIENT DISLOCATED ANTERIORLY, THE SURGEON ALSO DECIDED TO REVISE THE SHELL. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation

    MAUDE report 21400197 ↗
  • InjuryFeb 14, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT STARTED COMPLAINING A FEW MONTHS AGO ABOUT HER HIP FEELING ABNORMAL. X-RAYS REVEALED A PROBLEM WITH THE FEMORAL HEAD AND NECK COMBINATION...THE TRUNNION WAS WORN OFF...THE LINER WAS BASICALLY WORN AWAY..." THE HEAD PARTIALLY CAME OFF THE TRUNNION BECAUSE OF THE WEAR.

    Patient problems: Discomfort

    MAUDE report 21384854 ↗
  • InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    I&D OF A LEFT HIP WITH HEAD AND LINER EXCHANGE DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 21315172 ↗
  • InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AN I&D WITH HEAD/ LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 20770326 ↗
  • InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 20463013 ↗
  • InjuryOct 3, 2024Unstable; Unstable

    REVISED A LINER AND HEAD OF A RIGHT HIP DUE TO INSTABILITY. HE REVISED TO MDM.

    Patient problems: Joint Laxity

    MAUDE report 20358834 ↗
  • InjuryJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS PI IS FOR CLOSED REDUCTION ON (B)(6) 2023. PATIENT HAD AN INDEX LEFT THA ON (B)(6) 2023. PATIENT PRESENTED WITH INSTABILITY AND DISLOCATED THE LEFT HIP ON (B)(6) 2023, UNDERWENT A CLOSED REDUCTION. ON (B)(6) 2023 THE PATIENT PRESENTED WITH ANOTHER DISLOCATION EVENT, AND WAS REVISED, WITH HEAD AND LINER EXCHANGE ONLY.

    Patient problems: Joint Dislocation

    MAUDE report 19839478 ↗
  • InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT HAD AN INDEX LEFT THA ON (B)(6) 2023. PATIENT PRESENTED WITH PJI AND WAS REVISED ON (B)(6) 2023. ALL COMPONENTS WHERE EXCHANGED TO AN OFF-LABEL CONSTRUCT.

    Patient problems: Unspecified Infection

    MAUDE report 19838990 ↗
  • InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO WOUND DEHISCENCE. WHILE ADDRESSING THE ISSUE, SURGEON DECIDED TO REVISE THE HEAD AND LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Impaired Healing

    MAUDE report 19128094 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.