Trident 623-00-32DRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327039467), received between Jul 27, 2017 and Mar 6, 2025 — classified as 38 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RIGHT TOTAL HIP. THE REVISION TODAY WAS SECONDARY TO DISLOCATION. AFTER THE INDEX TOTAL HIP SURGERY THE PATIENT HAD EXTENSIVE LUMBAR SPINE SURGERY INCLUDING FUSION. THIS SPINE SURGERY WAS BELIEVED TO BE WHAT CAUSED THE JOINT TO BECOME UNSTABLE. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 21535311 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  "I HAVE BEEN EXPERIENCING COMPLAINTS ABOUT STRAIN ON MY LEFT LEG FOR SOME TIME NOW, STRYKER SYSTEM IS IMPLANTED. I EXPERIENCE PAIN AND LIMITATION WHEN STRAINING AND A THUMPING SOUND WHEN ROTATING THAT LEG. I ALSO HAVE OTHERS PAIN COMPLAINTS DEVELOPED THAT I DO NOT WANT TO GO INTO FURTHER DETAIL ABOUT NOW. IN MY OPINION THERE MAY BE SOMETHING WRONG WITH THE INSERT AND I'M TRYING THERETO GAIN CLARITY. SO FAR I HAVE BEEN TOLD THAT THE 'PROSTHESIS IS CORRECT', BUT THERE IS LITERATURE RESEARCH ON HOW OFTEN MISALIGNMENT OCCURS OF THE INSERT IS MISSED. AND THERE IS LITERATURE ABOUT THE X-RAY IMAGE THAT CONSISTENT WITH A MISPLACEMENT OR MISALIGNMENT. NOW I WOULD LIKE TO ASK YOUR COMPANY WHAT YOU THINK ABOUT THE CONDITION OF THE INSERT (TRIDENTX3 POLYETHYLENE INSERT) OF MY FULL HIP REPLACEMENT ON THE ATTACHED X RAY. AS YOU CAN SEE, THERE ARE TWO TRANSLUCENCIES VISIBLE ON THE LEFT AND RIGHT OF THE FEMORAL HEAD. AS I SEE IT, THESE ARE CHARACTERISTICS OF MISALIGNMENT/MISPLACEMENT: ELLIPTICAL (WEAR?) SPACES. IN ADDITION I SUSPECT SOME CRESCENT-SHAPED RADIOLUCENCY UNDER THE SHELL (TRITANIUM HEMISPHERICAL SOLID BLACK SHELL), WHICH IN MY OPINION COULD COME FROM MICRO MOTION AND NON-INGROWTH OF THE

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 19600976 ↗
• InjuryJan 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PRODUCT SPECIALIST THAT A PATIENT HAS ENCOUNTERED HIP DISLOCATION, REVISION THR DONE.

  Patient problems: Joint Dislocation

  MAUDE report 18500410 ↗
• InjuryJul 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PI FOR CLOSED REDUCTION. PATIENT REPORTED A CLOSED REDUCTION ON (B)(6) 2023 FOR A RIGHT HIP DISLOCATION PERFORMED IN THE EMERGENCY ROOM. PATIENT STATED SURGEON PLANS A REVISION AT THE END OF THE SUMMER. PATIENT WOULD LIKE TO KNOW IF PARTS SUBJECT TO A RECALL. PATIENT IS SEEKING COMPENSATION BUT HAS NOT YET RETAINED AN ATTORNEY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 17246082 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO EXPLANATION PROVIDED. THE PATIENT SELECTED "NO" FOR SATISFACTION. A FOLLOW-UP QUESTIONNAIRE WAS COMPLETED BY THE SUBJECT WHERE THEY ANSWERED "NO" FOR SATISFACTION WITH THE RESULTS OF THE STUDY HIP REPLACEMENT. THE PATIENT IS NOT SATISFIED DUE TO SHARP PAIN IN THEIR LEFT HIP. NO ADDITIONAL DETAILS CAN BE PROVIDED AS THIS WAS A PHONE VISIT AND NO CLINICAL NOTES WERE OBTAINED.

  Patient problems: Pain

  MAUDE report 15793596 ↗
• InjuryNov 7, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THROUGH A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2021. THE REVISION OPERATIVE REPORT NOTED "... DESTRUCTION OF THE TRUNNION, SEVERE METALLOSIS, SIGNIFICANT WEAR OF THE POLYETHYLENE AND METALLOSIS THROUGHOUT THE SYNOVIAL CAPSULE."

  Patient problems: Foreign Body Reaction

  MAUDE report 15742470 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, AN AE FOR BURSITIS WAS REPORTED. THE SUBJECT¿S CHIEF COMPLAINT WAS LEFT HIP AND THIGH PAIN, AS WELL AS TENDERNESS OVER THE GREATER TROCHANTER (GT) AND IT BAND. TREATMENTS HAVE INCLUDED LORTAB ON (B)(6) 2017, PHYSICAL THERAPY ON SEPTEMBER 18, 2019 AND MULTIPLE STEROID INJECTIONS IN MARCH AND APRIL 2017, AS WELL AS JANUARY AND AUGUST OF 2019. THE SUBJECT REPORTED ¿NO¿ TO BEING SATISFIED WITH HER STUDY HIP REPLACEMENT AT THE 5 YEAR VISITS. THE SUBJECT COMMENTED THAT HER PAIN HAS WORSENED COMPARED TO HER PREOPERATIVE STATE AND WAS VERY DISAPPOINTED.

  Patient problems: Discomfort; Pain

  MAUDE report 14656080 ↗
• InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "SHE PRESENTED WITH A DISLOCATED HIP. SHE CLAIMED IT HAPPENED ONCE BEFORE WHILE PRACTICING YOGA. DR. OPTED TO CHANGE HER HEAD/LINER CONSTRUCT TO AN MDM CONSTRUCT." REP CONFIRMED THAT THE HEAD HAD COME OUT OF THE LINER AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 14234499 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SUSPECTED INFECTION. PAIN. OSTEOLYSIS IN THE PROXIMAL PART OF THE FEMUR AND A TUMOR-LIKE SUBSTANCE CAN BE CONFIRMED ON CT. WEAR OF HEAD AND TMZF CANNOT BE DENIED. REVISION WILL BE DONE ON JUNE 9.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 12090797 ↗
• InjuryJun 18, 2021Contamination; Contamination

  THIS PI IS FOR THE ASPIRATION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2021. IN PROVIDING DOCUMENTS FOR A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2021 (PI 2717970), REP PROVIDED AN OFFICE NOTE WHICH NOTES: "I EXPLAINED THAT HER RIGHT HIP HAS BECOME INFECTED¿ASPIRATED 12CC OF FLUID WHICH HE DESCRIBED AS VISCOUS, CLOUDY, AND SEROSANGUINEOUS." REP PROVIDED OFFICE NOTES, PRIMARY USAGE SHEET, AND LAB RESULTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bacterial Infection

  MAUDE report 12024818 ↗
• InjuryJun 18, 2021Contamination; Contamination

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT HIP DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED OFFICE NOTES, PRIMARY USAGE SHEET, AND LAB RESULTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bacterial Infection

  MAUDE report 12024814 ↗
• InjuryJun 14, 2021Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT REPORTED SHE HAD A LEFT THA ON (B)(6) 2014. THE PATIENT WAS REVISED (B)(6) 2016 DUE TO THE SCREWS GOING INTO THE TENDONS. THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE SURGERY. THE PATIENT WENT TO THE ER ON (B)(6) 2021 HAD A CT SCAN AND WAS TOLD SHE HAD LOBULAR FLUID SURROUNDING HER LEFT HIP AND WAS TOLD TO FOLLOW UP WITH HER PHYSICIAN. THE PATIENT'S PHYSICIAN SENT HER FOR BLOOD WORK WHICH WAS DONE ON (B)(6) 2021 WHICH SHOWED HIGH LEVELS OF CHROMIUM. PATIENT WAS REVISED ON (B)(6) 2021. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR REVISION 1. THE PATIENT'S PHYSICIAN SENT HER FOR BLOOD WORK WHICH WAS DONE ON (B)(6) 2021 WHICH SHOWED HIGH LEVELS OF CHROMIUM. PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11996447 ↗
• InjuryMay 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT MAKO HIP WAS REVISED DUE TO DISLOCATION. REP CONFIRMED DISLOCATION AS HEAD AND LINER. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS OF IMPLANT MALPOSITION OR LOOSENING.

  Patient problems: Joint Dislocation

  MAUDE report 11892222 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT HIP - CUP, LINER, SCREW, HEAD BALL REVISION - FOR PAIN. NO OTHER INFO AVAILABLE." SPOKE TO REP: PATIENT WAS REVISED TO A COMPETITOR ACETABULAR SIDE. CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11732238 ↗
• InjuryFeb 15, 2021Material Erosion; Material Erosion

  REVISION SURGERY UPDATE 22 JANUARY 2021: THE SURGEON REPORTED THAT THE REVISION WAS DUE TO: TROCHANTERIC SYNDROME AND TRUNNIONOSIS. THE PATIENT FELT PAIN. HEAD AND LINER EXPLANTED. SLEEVE AND BIOLOX HEAD IMPLANTED ON DAMAGED TRUNNION. CHANGED THE LINER TO A 10 DEGREE LIP LINER, AND NOT PROCEEDING TO EXPLANT THE WELL FIXED FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 11327468 ↗
• InjuryDec 8, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO: "UNSTABLE TOTAL LEFT HIP." A TRIDENT HEMI CUP, 32 MM INSERT, AND TWO BONE SCREWS (25 MM AND 35 MM) WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 10972343 ↗
• InjuryNov 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PATIENT HAD EFFUSION, AND DEBRIDEMENT. RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 10867826 ↗
• InjurySep 25, 2020Material Erosion; Naturally Worn; Material Erosion; Naturally Worn

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEAD DISSOCIATION REPORTED AS GROSS TRUNNION FAILURE. BECAUSE OF THE AMOUNT OF METAL DEBRIS, LINER WEAR, AND IMPLANT STAINING, THE PATIENT'S ENTIRE HIP HAD TO BE REVISED. REP PROVIDED EXPLANT PICTURES AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 10586772 ↗
• InjurySep 15, 2020Unstable; Unstable

  PATIENT COMPLAINED OF RIGHT HIP WEAKNESS AND FALL (X2) ON (B)(6) 2019. PATIENT STATED THAT THE FALL WAS DUE TO RIGHT HIP WEAKNESS. RADIOGRAPHIC NOTES INDICATES NO LOOSENING, FRACTURE OR SUBSIDENCE. PATIENT NOT REVISED AS OF (B)(6) 2019.

  Patient problems: Insufficient Information

  MAUDE report 10533961 ↗
• InjuryJun 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED BECAUSE OF DISLOCATION. REMOVED HEAD AND LINER AND SWITCHED TO DUAL MOBILITY.

  Patient problems: Injury

  MAUDE report 10108869 ↗
• InjuryMay 19, 2020Naturally Worn; Naturally Worn

  DURING A THP REVISION FROM A PRIMARY ACCOLANDE TMZF/TRIDENT TRITANIUM IN (B)(6) 2019, THE SURGEON DISCOVERED THAT THE POLYETHYLENE WAS DAMAGED/SCRATCHED WITHOUT NOTICING CORPORA LIBERA. NO DAMAGE NOTICEABLE AT THE OLD V40 HEAD. THE DAMAGED X3 POLYETHYLENE ON THIS SHORT TERM IS CONCERNING THE COSTUMER ABOUT THE QUALITY. UPDATE: "1. REASON FOR REVISION (PLEASE INCLUDE ANY REPORTED PATIENT COMPLAINTS, PRE-OPERATIVE DIAGNOSES, AND INTRA-OPERATIVE FINDINGS): PERIPROSTETIC FRACTURE."

  Patient problems: Hip Fracture; Injury

  MAUDE report 10072605 ↗
• InjuryDec 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "THIS PATIENT'S MUSCULOSKELETAL COMORBIDITIES RESULTED IN MULTIPLE DISLOCATIONS OF THE HIP, REQUIRING REVISION OF THE ACETABULAR COMPONENTS (SHELL, SCREWS, X INSERT, FEMORAL HEAD). NO COMPLAINTS WERE MADE REGARDING THE COMPONENTS THEMSELVES." SPOKE TO REP. THE BIOLOX DELTA CERAMIC HEAD WAS DISLOCATING FROM THE X3 0° POLY INSERT. THERE ARE NO ALLEGATIONS AGAINST THE REVISED STRYKER DEVICES.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9512973 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT IN THE PAST 2 YEARS STUMBLES A LOT RIGHT HIP DOES NOT FEEL RIGHT, HARD TIME CLIMBING UPSTAIRS. UPDATE (B)(6) 2019 WG: REP WAS GIVEN A PRIMARY USAGE SHEET FROM (B)(6) 2011 AND A REVISION USAGE SHEET FROM (B)(6) 2019. THE ABGII MODULAR STEM, 32 -4 LFIT HEAD, AND 32D POLY LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH 3 DALL-MILES CABLE SETS, A 36 -5 BIOLOX HEAD, AND 36D INSERT. THE REP WAS NOT PRESENT FOR THE REVISION PROCEDURE AND HAS NO FURTHER INFORMATION (PRE-OP DIAGNOSES, PATIENT COMPLAINTS, INTRA-OPERATIVE FINDINGS) REGARDING THE REVISION. THE REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE (B)(6) 2019: AS PER RELATED PI, THE FOLLOWING WAS DOCUMENTED; 'PRE-OP DIAGNOSIS: MULTIPLE DISLOCATIONS S/P REVISION THA (PREVIOUS REVISION)'.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9311695 ↗
• MalfunctionNov 6, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING A THA (LEFT SIDE), AN INSERT WAS NOT LOCKED ON A CUP. A SPARE INSERT WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285387 ↗
• MalfunctionOct 14, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  A HAIR WAS FOUND IN THE PACKAGE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9185185 ↗