Trident 625-0T-32ERecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04546540516848), received between Jun 23, 2017 and Mar 12, 2024 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

1 other recall cover devices cleared under the same FDA submission (P000013); they may or may not involve this specific model.

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

• InjuryMar 12, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION PROCEDURE. CAUSE OF REVISION WAS PSEUDOTUMOUR. ALL PRIMARY IMPLANTS WERE REMOVED AND REPLACED BY A PROXIMAL FEMUR GMRS, CEMENTED CONSTRAINED LINER AND ACETABULAR CAGE OF COMPETITOR PRODUCT.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 18891630 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THA REVISION - LEFT. PRE-OP DIAGNOSIS: LEFT HIP PAIN. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL.

  Patient problems: Pain

  MAUDE report 15050647 ↗
• InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN IN FLEXION AND AUDIBLE CLICKING. A CERAMIC HEAD, INSERT AND METAL SLEEVE WERE REVISED TO A CERAMIC HEAD WITH POLY INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 14009757 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. AN ALUMINA HEAD AND LINER, ACCOLADE STEM, AND COMPETITOR CABLES AND PLATES WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 10763700 ↗
• InjurySep 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A DISLOCATION OF THEIR LEFT THR. UPDATE: (B)(6) 2020: THE PATIENT¿S HIP WAS SUCCESSFULLY RELOCATED IN THE ACCIDENT & EMERGENCY DEPT & DID NOT REQUIRE ADMISSION TO HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 10527954 ↗
• InjuryAug 25, 2020Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND SQUEAKING. AN ALUMINA HEAD AND LINER WERE REVISED. REP REPORTED THAT EXPLANT PICTURES CAN BE PROVIDED, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain

  MAUDE report 10451331 ↗
• InjuryAug 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD DISLOCATION OF THEIR LEFT THR.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10438586 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED THAT SHE HAD A THR AND WAS IMPLANTED WITH STRYKER IMPLANTS IN (B)(6) 2011. AFTER ABOUT 6 MONTHS THE CUSTOMER NOTICED PAIN IN BUTTOCK AND THIGH. DURING FOLLOW UP WITH HER CONSULTANT HE SUGGESTED THAT MICROMOTION MIGHT BE A POSSIBLE EXPLANATION AS THIS WAS A CEMENTED STEM, BUT THAT THIS COULD NOT DEFINITIVELY BE KNOWN THE PAIN EASED OFF BUT RECENTLY HAS RETURNED AND THE PATIENT REPORTS PAIN BEHIND THE SCAR AND PAIN IS ALSO NOTICEABLE DOWN HER LEG WHEN WALKING THE PATIENT HAS HAD SUBSEQUENT X-RAYS ON HER BACK TO INVESTIGATE THE PAIN THE PATIENT IS QUESTIONING WHETHER THERE MAY BE SOME METAL INTOLERANCE UNDERLYING THE ISSUE.

  Patient problems: Pain

  MAUDE report 9727940 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REP RECEIVED A MESSAGE FROM A PHYSICIAN ASSISTANT THAT PATIENT'S HIP WAS OBSERVED TO HAVE A FRACTURED CERAMIC LINER AND WILL BE REVISED. AS OF THE TIME OF REPORT, REP WAS GIVEN A LOT CODE FOR A TRIDENT E CERAMIC INSERT/SLEEVE AND WAS NOT MADE AWARE OF THE REVISION PLAN OR ANY OTHER PRE-OPERATIVE FINDINGS. PATIENT IS SCHEDULED FOR REVISION ON (B)(6) 2019. REP MAY BE ABLE TO PROVIDE OPERATIVE REPORT(S) AND USAGE SHEET(S) WHEN THE REVISION IS PERFORMED. HOSPITAL AND SURGEON HAS NO ACCESS TO FURTHER INFORMATION. UPDATE (B)(6) 2019: SPOKE TO REP. ORIGINAL PATIENT COMPLAINT WAS A GRINDING SENSATION IN THE HIP. INTRA-OPERATIVELY, NONE OF THE IMPLANTS WERE FOUND TO HAVE FRACTURED. THE CERAMIC LINER AND FEMORAL HEAD WERE REVISED TO AN X3 0° 32 D POLY LINER AND 32 +5 HEAD WITH SLEEVE. THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD.

  Patient problems: Injury

  MAUDE report 9310919 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2019 POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT 5 YEARS AGO. PATIENT HAD PAIN IN THE RIGHT HIP, IMAGING REVEALED DIFFUSE OSTEOLYSIS BEHIND THE SHELL AND THE PROXIMAL FEMUR, AND THE HIP PROSTHESIS APPEARED WELL FIXED. PATIENT UNDERWENT TOTAL HIP REPLACEMENT (B)(6) 2019. THE FEMORAL AND SHELL WERE RETAINED, THE MODULAR HEAD AND LINER WERE REMOVED. REPORTED IN CORS PER 1824HIP. NOW ((B)(6) 2019) THE PATIENT GETS REVISED AGAIN FOR A HEMATOMA, EXCHANGING THE HEAD AND LINER ONLY.

  Patient problems: Hematoma; Injury

  MAUDE report 8821685 ↗
• InjuryMay 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PER MEDICAL REVIEW, "ADDITIONALLY ON (B)(6) 2016 IT IS NOTED,"...ASPIRATION ... PURULENT MATERIAL AND INFECTED TOTAL HIP REPLACEMENT. PLAN ... REMOVAL ... ANTIBIOTIC SPACER." ON (B)(6) 2016 A "CT GUIDED ASPIRATION RIGHT HIP REVEALED 3ML PUS-LIKE MATERIAL". ON (B)(6) 2016 IT WAS NOTED, "GRAM POSITIVE COCCI, ON IV VANCOMYCIN, LEUKOCYTOSIS DECREASED TO 19,000." ON (B)(6) 2016 AN ''EXCISION AND DRAINAGE ... EXPLORATION, REMOVAL SOFT TISSUE, INSERTION ANTIBIOTIC BEADS WITH VANCOMYCIN AND TOBRAMYCIN" WAS PERFORMED FOR A PRE­ AND POST-OPERATIVE DIAGNOSIS OF INFECTED REVISION RIGHT TOTAL HIP ARTHROPLASTY." [...] "THE PATIENT WAS DISCHARGED ON (B)(6) 2016 TO REHAB ON INTRAVENOUS VANCOMYCIN. THE NOTE STATES, "BLOOD CULTURES WERE POSITIVE FOR STAPH."" [...] ""X-RAY PRINTOUTS RELATED TO THE RIGHT HIP INCLUDE A SERIES DATED (B)(6) 2016, WHICH IS AN AP OF THE PELVIS AND AN AP AND TWO LATERALS OF THE RIGHT HIP DEMONSTRATING A RESTORATION MODULAR UNCEMENTED LONG-STEM RIGHT TOTAL HIP ARTHROPLASTY. THE HIP IS REDUCED AND THE ACETABULUM IS GROSSLY LOOSE AND VERTICAL IN POSITION, AND HAD MIGRATED PROXIMALLY WITH A LARGE EXPANDED RADIOLUCENT ACETABULUM WITH TWO SCREWS VISIBLE."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8588541 ↗
• InjuryJan 29, 2019Fracture; Fracture

  A DOCTOR REPORTED THE FOLLOWING EVENT : " DECLARATION OF CERAMIC DEVICE FRACTURE REF (B)(4), LOT 50201602 ".

  Patient problems: Injury; Pain

  MAUDE report 8285514 ↗
• InjuryJan 22, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT, "HAD A TRIDENT HEMISPHERICAL RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2006." IT IS FURTHER REPORTED THAT, "ON (B)(6) 2007, THE PATIENT UNDERWENT REVISION OF THE RIGHT HIP." PER REVIEW OF MEDICAL RECORDS [...] "ON (B)(6) 2007 IT WAS NOTED SHE "BEGAN TO NOTICE SQUEAKING ON RIGHT HIP SINCE (B)(6) 2007, INCREASING, AND NOW GRINDING-LIKE AND RUSTY DOOR CLOSING".[...]IT WAS NOTED THAT HER HIP "READILY SQUEAKS AS SHE WALKS THROUGH THE OFFICE" AND THAT THE "SQUEAK IS UNACCEPTABLE TO HER''..."ON (B)(6) 2007 A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR WHICH AN OPERATIVE REPORT DESCRIBES REGIONAL ANESTHESIA AND A POSTEROLATERAL APPROACH FOR A DIAGNOSIS OF ASEPTIC FAILURE DUE TO BEARING SURFACE WEAR AND IMPLANT FAILURE. DURING SURGERY, THE "CERAMIC HEAD HAD A LARGE FOCUS OF STRIPE WEAR". THE ACETABULAR COMPONENT WAS "NOTED TO BE MODERATELY VERTICAL AND SEVERELY ANTEVERTED AT AROUND 60°". THREE SCREWS WERE REMOVED AFTER THE LINER AND THE CUP WAS REMOVED WITH THE IMPLEX ACETABULAR OSTEOTOME DEVICE WITH MINIMAL EVIDENCE OF BONE INGROWTH. "

  Patient problems: Injury

  MAUDE report 8267693 ↗
• InjuryJan 10, 2019Fracture; Fracture

  A (B)(6)-YEAR-OLD PATIENT, HOSPITALIZED FOR A REVISION OF A PROSTHESIS OF BIPOLAR RIGHT HIP FOLLOWING A FALL AT HOME IN (B)(6) 2018. IN (B)(6), THE PATIENT CONSULTS FOR SEVERE PAIN. WE RADIOLOGICALLY DETECTS A FRACTURE OF THE CERAMIC INSERT AT THE LEVEL OF THE RIGHT ACETABULUM. THIS WAS A 2009 HIP REPLACEMENT. THIS PI IS FOR THE BREAKAGE OF THE INSERT. THE OTHER DEVICES USED WERE NOT STRYKER DEVICES. THE PATIENT UNDERWENT SURGERY FOR BIPOLAR REVISION OF HIS HIP PROSTHESIS: TOTAL HIP REVISION. IN 2009, IT WAS ALSO A TOTAL HIP RECOVERY.

  Patient problems: Pain

  MAUDE report 8235113 ↗
• InjuryDec 19, 2018Degraded; Unstable; Malposition of Device; Degraded; Unstable; Malposition of Device

  PATIENT HAD COMPLAINED OF SUBLUXATION AND GRINDING OF HIP JOINT THAT WAS REPLACED IN 2007. WHEN SURGEON OPERATED AND DISLOCATED THIS JOINT THE CERAMIC LINER WAS FOUND TO HAVE A WORN SUPERIOR ASPECT OF THE LINER. SURGEON PERFORMED AN ACETABULAR REVISION. THE WORN LINER WAS NOTICED INTRAOPERATIVELY, HOWEVER THE PATIENT HAD BEEN COMPLAINING OF INSTABILITY PREVIOUSLY.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8182673 ↗
• InjuryOct 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  EXPLANTATION OF TRIDENT 0 DEGREE ALUMINA INSERT (ALPHA CODE E) AND V40 ALUMINA 32MM -4MM FEMORAL HEAD SECONDARY TO INFECTION AND SUBSEQUENT MDM LINER, X3 INSERT, 28MM CERAMIC HEAD, AND V40 UNIVERSAL ADAPTER SLEEVE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8021502 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION.

  Patient problems: Injury

  MAUDE report 7886574 ↗
• InjurySep 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PER MEDICAL REVIEW: ¿ON (B)(6) 2012 SHE WAS SEEN FOLLOW-UP FOR LEFT TOTAL HIP REVISION FOR RECURRENT DISLOCATION PERFORMED IN (B)(6) OF 2011 AND WAS NOTED TO BE "DOING VERY WELL, NOT MUCH IN THE WAY OF PAIN AND HIP STABLE, RETURN ONE YEAR".

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7857026 ↗
• InjurySep 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PER MEDICAL REVIEW: ¿ON (B)(6) 2011 A CLOSED REDUCTION AND MANIPULATION UNDER ANESTHESIA FOR A DISLOCATED LEFT TOTAL HIP WAS PERFORMED. IT WAS NOTED POST-REDUCTION TO BE UNSTABLE IN ADDUCTION AND INTERNAL ROTATION¿.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7856305 ↗
• InjurySep 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PER MEDICAL REVIEW: ¿ON (B)(6) 2009 THE LEFT TOTAL HIP ARTHROPLASTY DISLOCATED AND SHE HAD A MANIPULATION UNDER ANESTHESIA PERFORMED TO RELOCATE IT."

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7856121 ↗
• InjuryAug 8, 2018Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND AUDIBLE NOISE. PATIENT WAS REVISED FROM A CERAMIC HEAD AND LINER TO A 36 +5 CERAMIC HEAD WITH 36E POLY LINER.

  Patient problems: Injury; Pain

  MAUDE report 7763586 ↗
• InjuryJun 11, 2018Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  PHYSICIAN STATED LEFT HIP REVISION DUE TO SQUEAKING AND MALPOSITION OF ACETABULAR COMPONENT.

  Patient problems: Injury

  MAUDE report 7587786 ↗
• InjuryMay 25, 2018Noise, Audible; Noise, Audible

  REVISION LEFT TOTAL HIP REPLACEMENT. PATIENT EXPERIENCED SQUEAKING & PAIN IN HIP JOINT WHEN UNDER LOAD. REMOVED STRYKER CERAMIC ACETABULAR INSERT & BIOLOX DELTA V40 FEMORAL HEAD. REPLACED WITH TRIDENT X3 POLYETHYLENE INSERT & BILOX DELTA V40 CERAMIC HEAD.

  Patient problems: Injury; Pain

  MAUDE report 7546055 ↗
• InjuryDec 28, 2017Break; Fracture; Break; Fracture

  THE PATIENT FRACTURED THE LINER. SHE WAS REVISED TO A COMPETITOR HEAD WITH SLEEVE AND A POLY LINER.

  Patient problems: Injury

  MAUDE report 7152364 ↗
• MalfunctionJun 23, 2017Noise, Audible; Noise, Audible

  THERE WAS AN ABNORMAL SOUND AFTER PROSTHESIS IMPLANTATION.

  Patient problems: No Information

  MAUDE report 6663121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000013. One submission often covers many models, so check the product and lot details in each record.

• Z-1703-2009 · Jun 9, 2009 · Terminated
  Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.