Trident 623-00-44FRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327025422), received between Oct 2, 2018 and Oct 18, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Degraded” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNION WEAR AND METALLOSIS. INTRA-OPERATIVELY, LINER WEAR WAS ALSO NOTED. THE STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Metal Related Pathology

  MAUDE report 15621373 ↗
• InjuryJun 20, 2022Degraded; Degraded

  IT HAS BEEN REPORTED "CONE WEAR OF THE HIP STEM". ADDITIONAL INFORMATION FROM THE SURGEON: REVISION RIGHT HIP TEP VIA DORSAL APPROACH WAS PERFORMED ON (B)(6) 2021. ANALYSIS OF THE JOINT: METALOSIS, CONE OF THE HIP STEM USED UP, PE INLAY DAMAGED, CUP TRIDENT X3 /58MM FIXED, HEAD COCR 44MM/V40CONE. REMOVAL OF THE HIP STEM VIA TRANSFEMORAL APPROACH. THE CONE OF THE FEMORAL STEM WAS USED UP. THE FEMORAL HEAD IS LUXATED. HEAD DISASSOCIATION FROM THE FEMORAL STEM.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 14748363 ↗
• InjuryMar 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM FAILURE. INTRAOPERATIVELY, TRUNNION WEAR, METALLOSIS, HEAD TOGGLING ON TRUNNION, BLACK TISSUE, AND A BROKEN INSERT WERE NOTED. A 44 MM +4 V40 HEAD, TMZF PLUS STEM, AND 0° 44F INSERT WERE REVISED. REP CONFIRMED THAT ASIDE FROM PROVIDED PRIMARY USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Metal Related Pathology

  MAUDE report 11572156 ↗
• InjuryMay 28, 2019Naturally Worn; Naturally Worn

  PATIENT HAD REVISION HIP SURGERY BECAUSE BROKEN PRIMARY STEM. UPDATE (B)(6) 2019: REP PROVIDED AN OPERATIVE REPORT FOR THE (B)(6) 2019 REVISION WHICH CITES: "FAILED LEFT TOTAL HIP ARTHROPLASTY WITH COMPLETE RESORPTION OF THE TRUNNION AND SIGNIFICANT METALLOSIS DIFFUSELY ABOUT THE HIP COUPLED WITH SIGNIFICANTLY WEAK BONE SECONDARY TO THE METALLOSIS...POLYETHYLENE WAS REMOVED WHICH HAD AN ABNORMAL COLOR TO IT SECONDARY TO THE METALLOSIS...SIGNIFICANTLY WORN POSTERIORLY; HOWEVER, THERE WAS NO COMPLETE LOSS OF POLYETHYLENE..." REP ALSO PROVIDED PRE- AND POST-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE: "BLACK TISSUE WAS NOTED IN THE PATIENT INTRA-OPERATIVELY, PSEUDO-TUMOR WAS REPORTED, NO ELEVATED ION LEVELS AND THERE WAS WEAR AND DISCOLORATION OF THE LINER REPORTED."

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8647086 ↗
• InjuryFeb 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. REVISED A TOTAL HIP - THE LINER, HEAD AND SLEEVE FROM A 44 TO AN MDM DUE TO DISLOCATION. THE ORIGINAL SURGERY DATE WAS UNKNOWN, HOWEVER A REVISION SURGERY WAS DONE ON (B)(6) 2011 TO ADDRESS A LOOSE CUP.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8312688 ↗
• InjuryJan 7, 2019Degraded; Degraded

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION. INTRA-OPERATIVELY, PSEUDOTUMOR WAS REPORTED WITH AN EXCESSIVE AMOUNT OF BLACK TISSUE OBSERVED. THE TRUNNION WAS FOUND TO BE WORN DOWN AND THE LINER WAS WORN THROUGH IN AT LEAST 2 PLACES. THE SHELL WAS WELL-FIXED AND NOT REVISED. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A 28 +8 METAL HEAD.2

  Patient problems: Edema; Inflammation; Injury; Reaction

  MAUDE report 8222820 ↗
• InjuryOct 2, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO IMPINGEMENT OF THE COMPETITOR STEM WITH THE STRYKER SHELL AND/ OR LINER. STRYKER DEVICES REVISED: A 60MM SHELL WITH 2 SCREWS AND A 44F POLY LINER REVISED TO A 62MM SHELL WITH 2 SCREWS AND A 40MM G POLY LINER.

  Patient problems: Injury

  MAUDE report 7928150 ↗