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

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

Quick summary

This Trident X3 polyethylene hip implant insert is used in hip replacement surgery. The 26 reports mostly describe infections, hip dislocations or instability, and revision surgery. They include 26 injuries and no deaths. No recalls name this device; reports increased from 2 in the previous 12 months to 4 in the latest 12 months.

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
26
Deaths reported
0
Injuries reported
26
Recalls naming it
0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327342239), received between May 7, 2022 and Aug 31, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem16
  • Device Dislodged or Dislocated10
  • Unstable1

Patient problems

  • Unspecified Infection13
  • Joint Dislocation10
  • Pain3
  • Ambulation or Postural Difficulties2
  • Bone Fracture(s)2
  • Fall2
  • Anxiety1
  • Depression1

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 31, 2026Unstable

    It was reported that the patient's Left hip was revised due to instability. A 36 +0 ceramic head and 36F 0° insert were revised to an MDM metal liner, ADM/ MDM poly insert, 28 +5 C taper ceramic head, and adapter sleeve. Rep confirmed that no further information will be released by the hospital or surgeon.

    Patient problems: Joint Laxity

    MAUDE report 50516763 ↗
  • InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO NEW INFORMATION.

    Patient problems: Unspecified Infection

    MAUDE report 23826905 ↗
  • InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. A HEAD AND LINER EXCHANGE WITH PLACEMENTS OF ANTIBIOTIC BEADS AS A SPACER WAS PERFORMED (SPACER COMPONENTS WERE REMOVED 5 DAYS LATER). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 23533884 ↗
  • InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. A HEAD AND LINER WERE REVISED TO AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND BIOLOX HEAD WITH SLEEVE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation

    MAUDE report 23469260 ↗
  • InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS SUBJECT DID NOT PRESENT FOR STANDARD OF CARE FOLLOW UP AFTER HER SURGERY DUE TO FINANCIAL ISSUES AND LACK OF INSURANCE. SHE WAS ALSO IN THE PROCESS OF APPLYING FOR DISABILITY, WHEN CONTACTED VIA TELEPHONE ON 01OCT2024, THE SUBJECT COMPLAINED THAT PAIN WAS AFFECTING HER MOBILITY AND DESIRED TO BE MEDICALLY EVALUATED ONCE HER DISABILITY AND MEDICAID WAS APPROVED. SHE STATED SHE WAS DISSATISFIED WITH HER HIP SURGERY AND REPORTED AN EQ-5D VAS SCORE OF 0. SHE ALSO REPORTED THAT SHE WAS MODERATELY ANXIOUS AND DEPRESSED AND WAS SEPARATING FROM HER HUSBAND. WHEN SHE DID PRESENT FOR FOLLOW UP ON 02APRIL2025, HER MAIN COMPLAINTS WERE BILATERAL KNEE PAIN AND SHE WAS STATUS POST LUMBAR SPINE STEROIDAL INJECTIONS. LEFT HIP.

    Patient problems: Anxiety; Depression; Loss of Range of Motion; Pain

    MAUDE report 21924494 ↗
  • InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD A PRIMARY LEFT THA ON (B)(6) 2023. THE PATIENT DEVELOPED PJI. THE PATIENT WAS REVISED ON (B)(6) 2023, ALL COMPONENTS WERE EXCHANGED.

    Patient problems: Unspecified Infection

    MAUDE report 21342996 ↗
  • InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED: "REV R THA FOR INFECTION, DOING A SINGLE STAGE REVISION HIP AND GOING BACK IN WITH RESTORATION MODULAR." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 20509768 ↗
  • InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REVISED FIRST STAGE REVISION FOR INFECTION ALL ORIGINAL IMPLANTS REMOVED AND REPLACED WITH CEMENT SPACER EXETER RIMFIT AND STEM TO RETURN FOR 2ND STAGE REVISION IN 6-8 WEEKS.

    Patient problems: Unspecified Infection

    MAUDE report 20449413 ↗
  • InjuryJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AS REPORTED: "LEFT-HIP REVISION. PT PRESENTED WITH A DISLOCATED LEFT-HIP FOLLOWING THA SURGERY (HEAD CAME OUT OF THE LINER). DR. DETERMINED THE ACETABULAR SHELL WAS NOT IN AN OPTIMAL POSITION FOR ENSURING HIP STABILITY AND DECIDED TO REVISE THE SHELL. HE OPTED TO CHANGE FROM A STANDARD X3 INSERT TO AN MDM CONSTRUCT FOR ADDITIONAL DISLOCATION-PRECAUTION." REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation

    MAUDE report 19838989 ↗
  • InjuryJul 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRING DISLOCATIONS. THE HEAD, SLEEVE AND LINER WERE REVISED TO A CONSTRAINED LINER WITH A NEW HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation

    MAUDE report 19802076 ↗
  • InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO POTENTIAL 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 19527998 ↗
  • InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 19349792 ↗
  • InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING WAS REPORTED: LINER AND HEAD OF A LEFT HIP REVISED DUE TO ARTHROTOMY DAMAGE. DID A FULL WASHOUT I&D AS A PRECAUTION IN CASE IT WAS INFECTED. THERE WERE NO SIGNS OF PUSS.

    Patient problems: Discomfort

    MAUDE report 17438995 ↗
  • InjuryJul 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS PI IS FOR CLOSED REDUCTION PERFORMED ON (B)(6) 2022. THE PATIENT HAD PRIMARY SURGERY (UNKNOWN IF STRYKER COMPONENTS) IN THE RIGHT HIP APPROXIMATELY THE YEAR 2011. A STRYKER CONSTRUCT WAS FIRST RECORDED TO BE IMPLANTED IN THE PATIENT'S RIGHT HIP ON (B)(6) 2022. THIS REVISION PROCEDURE REPORTEDLY WAS INTENDED TO ADDRESS THE PATIENT¿S CHRONIC PAIN, A FALL, DISLOCATION, AND POLYETHYLENE LINER DISASSOCIATION. A GROSSLY LOOSE ACETABULAR COMPONENT WITH PROXIMAL MIGRATION, TRANSVERSE PELVIC DISCONTINUITY, AND MASSIVE ACETABULAR BONE LOSS WERE ALSO REPORTEDLY OBSERVED AT THIS TIME OF PRIMARY STRYKER IMPLANTATION. A BONE GRAFT WAS PERFORMED TO ADDRESS THE ACETABULAR FRACTURE. RECURRENT DISLOCATIONS WERE THEN REPORTED FOLLOWING THIS PROCEDURE AND WERE FIRST ADDRESSED ON (B)(6) 2022 THROUGH CLOSED REDUCTION. LEADING UP TO THIS AUGUST CLOSED REDUCTION, IT WAS REPORTED THAT "[THE PATIENT] PARTICIPATED IN PHYSICAL THERAPY LAST THURSDAY AND FELT PAIN WHILE WALKING WITH HER WALKER BACK TO HER ROOM IN THE REHAB FACILITY.

    Patient problems: Ambulation or Postural Difficulties; Fall; Joint Dislocation; Pain

    MAUDE report 17394680 ↗
  • InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT AS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. AN I&D WITH HEAD LINER EXCHANGE WAS PERFORMED.

    Patient problems: Unspecified Infection

    MAUDE report 17330115 ↗
  • InjuryMay 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS PI FOR PRIMARY TO CERCLAGE. SON OF PATIENT STATED HIS MOTHER HAD PRIMARY RIGHT HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, PATIENT EXPERIENCED INCREASE PAIN AND AN X-RAY CONFIRMED A 1/2 INCH WIDE BREAK. IT WAS ALSO STATED THAT ON (B)(6) 2022 A "CAGE WAS ADDED" DUE TO HER IMPLANT "POPPING OUT", TWICE. SON DID NOT CONFIRM WHAT WAS POPPING OUT. A REVISION WAS THEN PERFORMED ON (B)(6) 2023, "HEAD AND CUP" WERE REPLACED WITH COMPETITOR PRODUCTS. UPDATE: LEADING UP TO THIS AUGUST CLOSED REDUCTION, IT WAS REPORTED THAT "[THE PATIENT] PARTICIPATED IN PHYSICAL THERAPY LAST THURSDAY AND FELT PAIN WHILE WALKING WITH HER WALKER BACK TO HER ROOM IN THE REHAB FACILITY. THE NEXT DAY, WHEN SHE WAS STANDING UP WITH HER WALKER AND REACHING FOR SOMETHING ON HER SHELF, SHE FELT A 'POP' AND HAD TO IMMEDIATELY SIT ON THE BED. SHE DID NOT FALL OR HIT HER HEAD. X-RAYS OBTAINED AT THE FACILITY WERE CONSISTENT WITH REPEAT DISLOCATION." THE PATIENT THEN UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 DUE TO DISLOCATION AND ¿ACETABULAR FAILURE¿ WHEREBY THE PATIENT WAS CONVERTED TO A STRYKER CONSTRAINED LINER.

    Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Inadequate Osseointegration; Insufficient Information; Joint Dislocation; Pain

    MAUDE report 17009042 ↗
  • InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED: "PATIENTS RIGHT HIP HAD POLY AND HEAD SWAPPED DUE TO INFECTION. INITIAL OP DATE WAS (B)(6) 2022. ALL INFORMATION ON THIS PATIENT IS INCLUDED."

    Patient problems: Unspecified Infection

    MAUDE report 15585124 ↗
  • InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD A PRIMARY THA ON (B)(6) 2021. THE PATIENT DEVELOPED AN INFECTION OF THE RIGHT HIP AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021.

    Patient problems: Unspecified Infection

    MAUDE report 15307909 ↗
  • InjuryAug 2, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE, WHICH CONTRIBUTED TO STEM SUBSIDENCE, WHICH CONTRIBUTED TO DISLOCATION OF THE HEAD FROM THE LINER. THE FEMORAL HEAD WAS REVISED TO ANOTHER HEAD AND SLEEVE WITH A LONGER NECK. STEM AND LINER WERE RETAINED.

    Patient problems: Bone Fracture(s); Joint Dislocation

    MAUDE report 15144665 ↗
  • InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Unspecified Infection

    MAUDE report 15143543 ↗
  • InjuryJun 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT REPORTED A 4TH LEFT HIP DISLOCATION ON (B)(6) 2022 WHICH WAS TREATED TO "POP BACK" AND NOTHING WAS REMOVED. PATIENT WOULD LIKE TO KNOW IF PARTS ARE SUBJECT TO A RECALL. PATIENT INDICATED HE IS IN THE PROCESS OF RETAINING AN ATTORNEY.

    Patient problems: Joint Dislocation

    MAUDE report 14826635 ↗
  • InjuryJun 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS PI IS FOR DISLOCATION REDUCTION ON MARCH 24, 2022. PATIENT REPORTED PRIMARY SURGERY ON (B)(6) 2022 AND REPORTED 3 LEFT HIP DISLOCATIONS WITH THE MOST RECENT ON (B)(6) 2022. MARCH 24, 2022: 1ST DISLOCATION (APPROX). ON (B)(6) 2022: 2ND DISLOCATION (APPROX). ON (B)(6) 2022: 3RD DISLOCATION (APPROX). EACH DISLOCATION WAS TREATED TO "POP BACK IN", NOTHING WAS REMOVED.

    Patient problems: Joint Dislocation

    MAUDE report 14800077 ↗
  • InjuryJun 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THIS PI IS FOR DISLOCATION REDUCTION ON (B)(6) 2022. PATIENT REPORTED PRIMARY SURGERY ON MARCH 8, 2022 AND REPORTED 3 LEFT HIP DISLOCATIONS WITH THE MOST RECENT ON (B)(6) 2022. PATIENT WOULD LIKE TO KNOW IF PARTS ARE SUBJECT TO A RECALL. PATIENT INDICATED HE IS IN THE PROCESS OF RETAINING AN ATTORNEY. (B)(6) 2022: 1ST DISLOCATION (APPROX), (B)(6) 2022: 2ND DISLOCATION (APPROX), (B)(6) 2022: 3RD DISLOCATION (APPROX), EACH DISLOCATION WAS TREATED TO "POP BACK IN", NOTHING WAS REMOVED.

    Patient problems: Joint Dislocation

    MAUDE report 14772869 ↗
  • InjuryJun 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PATIENT REPORTED PRIMARY SURGERY ON (B)(6) 2022 AND REPORTED 3 LEFT HIP DISLOCATIONS WITH THE MOST RECENT ON (B)(6) 2022. PATIENT WOULD LIKE TO KNOW IF PARTS ARE SUBJECT TO A RECALL. PATIENT INDICATED HE IS IN THE PROCESS OF RETAINING AN ATTORNEY. (B)(6) 2022: 1ST DISLOCATION (APPROX). (B)(6) 2022: 2ND DISLOCATION (APPROX). (B)(6) 2022: 3RD DISLOCATION (APPROX). EACH DISLOCATION WAS TREATED TO "POP BACK IN", NOTHING WAS REMOVED. THIS IS FOR DISLOCATION REDUCTION ON (B)(6) 2022.

    Patient problems: Joint Dislocation

    MAUDE report 14691885 ↗
  • InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED: "LEFT HIP REVISION DUE TO INFECTION. HEAD AND LINER WERE EXCHANGED. NO MORE INFORMATION IS AVAILABLE PER DOCTOR. INFECTION WAS CONFIRMED."

    Patient problems: Unspecified Infection

    MAUDE report 14470908 ↗

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.