Trident X3 Insert 723-10-36FRecalls & reported problems
Howmedica Osteonics Corp. · Trident X3 10 Degree Polyethylene Insert · Class 2 · Implant
All models of Trident X3 Insert (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327339574), received between Aug 17, 2022 and Jun 29, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated2
- Detachment of Device or Device Component1
- Unstable1
Patient problems
- Unspecified Infection5
- Joint Dislocation2
- Ambulation or Postural Difficulties1
- Bacterial Infection1
- Joint Laxity1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: 2 OF 2: "I WAS WONDERING IF YOU CAN HELP US. WE RECENTLY HAVE 2 THR SURGICAL SITE INFECTIONS WHICH OCCURRED TO PATIENTS WE OPERATED ON A WEEK APART. BOTH OF THEM HAD VERY SIMILAR PRESENTATIONS IN THAT THE INFECTION WAS VERY AGGRESSIVE AND PATIENTS BECAME ACUTELY UNWELL. THEY HAVE GROWN THE SAME ORGANISM CALLED FUSOBACTERIUM NECROPHORUM WHICH IS QUITE UNUSUAL TO BE FOUND IN THRS. I HAVE LOOKED AT THE COMMONALITIES BETWEEN CASES AND THE ONLY THING I FOUND IN COMMON IS THE BATCH NUMBER FOR THE LINERS WHICH ARE: 723-10-36F; ACETABULAR LINER - POLY TRIDENT; F COMP 36MM (10 DEG) 9N2NTJ 05/01/2031. I MEAN THIS COULD BE A VERY RARE COINCIDENCE BUT WE WOULD JUST LIKE TO EXPLORE IF THERE HAS BEEN ANY RECALL OR ANYTHING THAT HAS BEEN FLAGGED UP IN TERMS OF CONTAMINATION ISSUES DURING THE MANUFACTURING PROCESS? "
Patient problems: Bacterial Infection
MAUDE report 25651441 ↗InjuryMay 12, 2026Unstable
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF A LEFT TOTAL HIP REPLACEMENT. IT WAS REPORTED THAT THE PATIENT LOST A LARGE AMOUNT OF WEIGHT AFTER THE INDEX SURGERY AND BECAME UNSTABLE. THE CONSTRUCT WAS CONVERTED FROM A 36MM WITH 10 DEGREE TO AN MDM CONSTRUCT WITH A LONGER NECK LENGTH FOR STABILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL.
Patient problems: Joint Laxity
MAUDE report 25147076 ↗InjuryNov 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT LEFT HIP REVISED DUE TO DISLOCATION. HEAD AND LINER EXCHANGED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Joint Dislocation
MAUDE report 23642579 ↗InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY THE SALESPERSON THAT PATIENT UNDERGOES PRIMARY THR@ ON (B)(6) 2024, REQUIRE FOR REVISION THR @ ON (B)(6) 2025 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23076061 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REP WAS INFORMED THAT THE PATIENT'S RIGHT HIP WOULD BE REVISED THE NEXT DAY FOR INFECTION. AN I&D WITH POLY SWAP WILL BE PERFORMED. NO STRYKER REP WILL BE PRESENT FOR THE PROCEDURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 23057825 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED WITH SYMPTOMS OF AN ACUTE INFECTION OF THE LEFT HIP FOLLOWING A MAKO-THA ON (B)(6) 2024. SURGEON OPTED TO DO AN EXTENSIVE I&D OF THE LEFT HIP AND SWAP OUT THE X3 INSERT AND BIOLOX HEAD. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES; ALL OTHER COMPONENTS WERE LEFT IN-SITU. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 20614556 ↗InjuryJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY SALE REP THAT THERE IS A REVISION HIP PERFORMED DUE TO HEAD FALLS OF LINER. PRIMARY SURGERY PERFORMED (B)(6) 2024.
Patient problems: Joint Dislocation
MAUDE report 19473587 ↗InjuryMay 15, 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 SUSPECTED INFECTION. AN I&D WAS PERFORMED, AND THE FEMORAL HEAD AND LINER EXCHANGED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 19318324 ↗InjuryNov 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT REPORTED HEARING A POP IN HIS HIP AND AFTERWARDS, THE HIP STARTED SQUEAKING. IT WAS DETERMINED THAT THE LINER DISSOCIATED FROM THE SHELL, ALLOWING THE FEMORAL HEAD TO RUB INSIDE THE SHELL. INTRA-OPERATIVELY, THE SURGEON COULD NOT DETERMINE WITH CERTAINTY IF ONE OF THE SCREWS WAS PROUD BUT COULD NEITHER LOOSEN NOR TIGHTEN IT AS IT WAS STRIPPED, SO THE SURGEON BURRED THE HEAD DOWN TO BE CERTAIN. THE HEAD AND THE LINER WERE REVISED.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 15797083 ↗InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HIP REVISION DUE TO INFECTION. ACCOLADE II STEM REMOVED, TRIDENT PSL CUP, LINER AND SCREWS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 15238421 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
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- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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