Trident 623-10-36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07613327039917), received between Mar 7, 2017 and Nov 27, 2024 — classified as 55 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM, LINER WEAR, AND TRUNNION WEAR. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20800192 ↗
• InjuryApr 17, 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 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 19129011 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HAVING PAIN IN LEFT HIP AND WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Pain

  MAUDE report 18444576 ↗
• InjuryOct 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH A DISLOCATED HIP. THA REVISION WAS PERFORMED TO REPLACE LINER AND HEAD WITH MDM CONSTRUCT UPDATE: "HEAD CAME OUT OF LINER. MDM INSERT WAS USED IN ORDER TO HAVE A LARGER EFFECTIVE HEAD INCREASING JUMP DISTANCE."

  Patient problems: Joint Dislocation

  MAUDE report 15555965 ↗
• InjuryJul 1, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY MPS: "I COVERED A HIP REVISION TODAY DUE TO TRUNNIONOSIS FAILURE IN THE RIGHT HIP HEAD DISSOCIATION." SPOKE TO MPS. A STEM, HEAD AND LINER WERE REVISED. EXPLANT PICTURE FOR THE LINER SHOWS DAMAGE ON THE RIM. THE MPS CANNOT CONFIRM IF THAT DAMAGE WAS PRESENT IN SITU OR IF IT IS EXPLANT DAMAGE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14886844 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SURGEON NOTIFIED ON A POSSIBLE IMPLANT REMOVAL CASE DUE TO INFECTION. REFER X-RAY IN INTAKE TAB. DATE OF REVISION SURGERY WILL BE ADVISED BY SALES REP. THE PRIMARY SURGERY WAS ON (B)(6) 2019.

  Patient problems: Unspecified Infection

  MAUDE report 14749187 ↗
• InjuryMay 26, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT (B)(6) 2007 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. UPDATE ON 05-MAY-2022 BASED ON REVISION OP REPORT: "PRE-OP DIAGNOSIS: FAILED LEFT TOTAL HIP ARTHROPLASTY - BROKEN FEMORAL STEM AND DAMAGED LINER; METALLOSIS LEFT HIP. POST-OP DIAGNOSIS: SAME IMPLANTS: REMOVED: STRYKER ACCOLADE 1 TMZF WITH 36 HEAD AND DAMAGED 50 MM LINER AND 36/0 METAL HEAD; INTRAOPERATIVE FINDINGS: BROKEN FEMORAL STEM (TRUNNION FAILURE) AND DAMAGED LINER WITH EXTREME METALLOSIS AND BLACK STAINING OF TISSUES. THERE WAS WELL FIXED PSL CUP AND ACCOLADE STEM THAT WAS WELL FIXED. THE HIP WAS DISLOCATED ALREADY DUE TO FAILED TRUNNION.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 14519936 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A 36 0 BIOLOX HEAD AND 36E 10° INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 14304682 ↗
• InjuryMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATIONS OF THE HEAD FROM THE LINER. INTRA-OPERATIVELY, SOME METALLOSIS AND BLACK DEBRIS ON THE TRUNNION WERE NOTED. THE HEAD AND LINER WERE REVISED TO ANOTHER FEMORAL HEAD AND CONSTRAINED LINER.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 13716571 ↗
• InjuryDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE POLY INSERT. THE INSERT (IMPLANTED (B)(6) 2021), FEMORAL HEAD AND RESTORATION MODULAR PROXIMAL BODY (IMPLANTED (B)(6) 2021) WERE REVISED TO A NEW PROXIMAL BODY AND HEAD, MDM/ ADM POLY INSERT, AND MDM METAL LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED PROXIMAL BODY.

  Patient problems: Joint Dislocation

  MAUDE report 13029175 ↗
• InjuryNov 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD THEIR [LEFT] HIP REPLACED ON (B)(6) 2021, PRESENTED THIS WEEK WITH SYMPTOMS INDICATIVE OF AN ACUTE INFECTION. FOLLOWING BLOOD WORK AND TESTING, DR. DECIDED ON PERFORMING AN I&D AND REMOVAL OF SOME IMPLANTS. THE BIOLOX HEAD AND X3 INSERT WE¿RE SWAPPED OUT AS PART OF DR'S I&D PROTOCOL. THE TWO 6.5MM SCREWS WERE REMOVED AS WELL. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS THEMSELVES."

  Patient problems: Unspecified Infection

  MAUDE report 12877935 ↗
• InjuryNov 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN PROVIDING INFORMATION FOR LEGAL PI FOR A RIGHT HIP REVISION ON (B)(6) 2020, AN OPERATIVE REPORT WAS PROVIDED INDICATING THE PATIENT HAD DISLOCATIONS TREATED WITH CLOSED REDUCTIONS ON (B)(6) 2019, (B)(6) 2019, AND (B)(6) 2020. THIS PI IS FOR THE DISLOCATION AND CLOSED REDUCTION ON (B)(6) 2020.

  Patient problems: Joint Dislocation

  MAUDE report 12819151 ↗
• InjuryNov 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN PROVIDING INFORMATION FOR LEGAL (B)(6) FOR A (B)(6)REVISION ON (B)(6) 2020, AN OPERATIVE REPORT WAS PROVIDED INDICATING THE PATIENT HAD DISLOCATIONS TREATED WITH CLOSED REDUCTIONS ON (B)(6) 2019, AND (B)(6) 2020. THIS PI IS FOR THE DISLOCATION AND CLOSED REDUCTION ON (B)(6) 2019.

  Patient problems: Joint Dislocation

  MAUDE report 12817620 ↗
• InjuryNov 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN PROVIDING INFORMATION FOR LEGAL PI FOR A RIGHT HIP REVISION ON 16/JUNE/2020, AN OPERATIVE REPORT WAS PROVIDED INDICATING THE PATIENT HAD DISLOCATIONS TREATED WITH CLOSED REDUCTIONS ON (B)(6) 2019 AND (B)(6) 2020. THIS PI IS FOR THE DISLOCATION AND CLOSED REDUCTION ON 24/NOVEMBER/2019.

  Patient problems: Joint Dislocation

  MAUDE report 12817590 ↗
• InjuryJun 8, 2021Adverse 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 WASHOUT AND HEAD AND POLY EXCHANGE WAS DONE. A DELTA V-40 CERAMIC HEAD AND TRIDENT X3 36 MM INSERT WERE EXPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11957620 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH DRAINING OF HIS SURGICAL WOUND, FROM A [LEFT] THA PERFORMED ON (B)(6) 2021. DR. SWAPPED OUT THE ¿FEMORAL HEAD AND LINER¿ AS PART OF HIS I&D PROTOCOL. EXPLANTED ITEMS FROM THE (B)(6) 2021 SURGERY WERE THE FEMORAL HEAD AND X3 INSERT. SURGEON OPTED TO SWAP HEAD-TAPER AS WELL BY USE OF A V40/C-TAPER SLEEVE. NO COMPLAINTS FILED AGAINST IMPLANTS, EXPLANTS ARE NOT AVAILABLE FOR RETURN AS PER HOSPITAL-POLICY, NO FURTHER INFO AVAILABLE." SPOKE TO REP: INFECTION IS SUSPECTED BUT NOT CONFIRMED YET.

  Patient problems: Unspecified Infection

  MAUDE report 11684826 ↗
• InjuryApr 2, 2021Degraded; Degraded

  IT HAS BEEN REPORTED "AN EMAIL HAS BEEN RECEIVED FROM A MEDICAL EXAMINER COMMISSIONED BY A PRIVATE HEALTH FACILITY TO PREPARE A MEDICAL-LEGAL OPINION ON A PAINFUL HIP POST PROSTHESIS WITH TRIDENT PSL ACETABULUM. HA, TRIDENT X3 POLYETHYLENE INSERT AND LFIT ANATOMIC FEMORAL HEAD. THE PLACEMENT OF THE PROSTHESIS TOOK PLACE IN (B)(6) 2010; IN (B)(6) 2013 THE PROSTHESIS WAS SUBJECTED TO REVISION WITH REPLACEMENT OF THE ACETABULUM AND THE INSERT THAT HAD DEBRIS. IN THE OPERATING REPORT, AMONG OTHER THINGS, REPORTED: ARTHROTOMY. ABUNDANT "SAWDUST" MATERIAL IS FOUND SURROUNDING THE CUP AND AFFECTING THE FEMORAL EPIPHYSIS. IT IS CAREFULLY REMOVED AND ABUNDANTLY WASHED. THIS MATERIAL IS DUE TO THE DEBRIS OF THE ACETABULAR POLYETHYLENE, THEREFORE IT IS REMOVED. THE RADIOLOGICAL ASSESSMENTS FROM 2010 TO 2013 DID NOT HIGHLIGHT ANY LOOSENING OF THE PROSTHESIS OR IMPLANT DEFECTS".

  Patient problems: Pain

  MAUDE report 11607118 ↗
• InjuryJan 27, 2021Adverse 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. AS REPORTED BY REP: "REVISION DUE TO PAINFUL JOINT. NO OTHER FINDINGS OR INFORMATION AVAILABLE." A 36+5 LFIT HEAD AND 36E 10° POLY INSERT WERE REVISED TO A 28MM BIOLOX HEAD, +4 SLEEVE, ADM/ MDM POLY INSERT, AND MDM METAL LINER. SPOKE TO REP, WHO SUPPLIED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11235146 ↗
• InjuryJan 4, 2021Adverse 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 INFECTION. A HEAD AND LINER EXCHANGE AND WASHOUT WAS DONE. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Unspecified Infection

  MAUDE report 11108937 ↗
• InjuryDec 10, 2020Degraded; Degraded

  ITS ALLEGED BY THE ATTORNEY THROUGH THE FILING OF A LAWSUIT THAT THE PLAINTIFF UNDERWENT A RIGHT THA ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT PLAINTIFF BEGAN EXPERIENCING DISCOMFORT AND PAIN IN THE AREA OF THE IMPLANTED DEVICE. BONE SCANS ORDERED ON (B)(6) 2017 DEMONSTRATED EVIDENCE OF LOOSENING IN THE HIS RIGHT HIP. THE PLAINTIFF HAS NOT BEEN REVISED. REVISION (B)(6) 2018. MED REVIEW PERFORMED IN 2020 CONFIRMS WEAR OF THE TRIDENT LINER.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10987266 ↗
• InjuryDec 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR REPORTS PATIENT A STATUS POST LEFT TOTAL HIP DONE ON (B)(6) 2020 HAD A FALL WHICH PUSHED THE CUP THROUGH THE MEDIAL WALL AND CAUSED A DISLOCATION. DR REQUESTED TO REVISE BOTH THE CUP AND FEMORAL SIDE. ALL IMPLANTS WERE REMOVED. A NEW TRITANIUM CUP MDM LINER RESTORATION MODULAR STEM AND HEAD WERE IMPLANTED PER SURGICAL TECHNIQUE. UPDATE PER SALES REP: BECAUSE THE STEM HAD BEEN IN SITU FOR ONLY 2 WEEKS, THE SURGEON DECIDED TO REMOVE IT IN ORDER TO HAVE BETTER ACCESS TO THE ACETABULUM. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED STEM.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 10934115 ↗
• InjuryNov 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPETITOR FORWARDED AN EMAIL FROM A PATIENT: "I HAD A HIP REPLACEMENT IN 2014 THAT FAILED EARLIER THIS YEAR. I AM TRYING TO FIND OUT IF THE PARTS THAT WERE USED WERE RECALLED OR SHOULD NOT HAVE BEEN USED IN COMBINATION. THE PART WAS (COMPETITOR FEMORAL) USED WITH STRYKER TRITANIUM CUP AND COBALT CHROME ON POLYETHYLENE ARTICULATION. COULD I KINDLY HAVE A COPY OF THE INSTRUCTIONS FOR USE PLEASE." UPDATE: AS PER PATIENT, SHE HAS A RIGHT THA DONE ON (B)(6) 2014. SHE STARTED EXPERIENCING PAIN (B)(6) 2019 ON HER RIGHT HIP. SHE HAD PHYSICAL THERAPY FOR APPROX A FEW MONTHS. THE PATIENT STATED HER LEG WAS WEAKER AND IT FELT AS SHE WAS DRAGGING HER LEG. ON (B)(6) 2020 HER LEG COMPLETELY GAVE OUT, SHE HAD TO USE A WALKER. FROM AN X-RAY IMAGE AND MRI GIVEN, THE PATIENT WAS TOLD SHE HAD FLUID, BUT TREATMENT WAS NOT GIVEN. THE PATIENT COULD NOT STRAIGHTENED HER LEG. THE SURGEON SENT THE PATIENT FOR BLOOD WORK AND THE RESULTS SHOWED HIGH LEVELS OF CHROMIUM AND COBALT. THE PATIENT WAS RECOMMENDED TO TWO SURGEONS AND SHE CHOOSE THE ONE WITH AVAILABILITY. IN THE MIDDLE OF (B)(6) 2020 THE SURGEON REVIEWED HER PREVIOUS MRI RESULTS AND AN X-RAY IMAGE THEY TOOK AND WAS TOLD THAT SHE NEEDED REVISION. PA

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 10823462 ↗
• InjuryOct 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER HAVING A PRIOR REVISION ON THE SAME DAY, THE PATIENT DISLOCATED. A 36E 10° INSERT WAS REVISED TO A 36E 0° INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 10751752 ↗
• InjuryOct 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT REPORTED PAIN AND INSTABILITY IN HIS RIGHT HIP. ORIGINAL HIP REPLACEMENT WAS PERFORMED IN 2012 AT AN OUTSIDE FACILITY. IMAGING SHOWED A COMPLETE DISASSOCIATION FROM THE FEMORAL HEAD COMPONENT OFF THE TRUNNION OF THE FEMORAL STEM COMPONENT. DURING THE PROCEDURE ADVERSE LOCAL TISSUE REACTION WAS REPORTED BY THE SURGEON, AS WELL AS THE TRUNNION WEARING THROUGH THE POLYETHYLENE LINER OF THE HIP AND INTO THE ACETABULAR COMPONENT DAMAGING THE LOCKING MECHANISM. ALL 5 COMPONENTS IMPLANTED DURING THE INDEX PROCEDURE WERE STRYKER COMPONENTS, THEY WERE REMOVED FROM THE PATIENT AND REVISED WITH STRYKER COMPONENTS. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10740827 ↗
• InjurySep 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. SURGEON REPORTED INFECTION BEGAN AT THE SITE OF A PRIOR CERVICAL FUSION AND MIGRATED. SURGEON ALSO CITED PATIENT'S POOR BLOOD FACTORS TO BE A CONTRIBUTOR. SURGEON PERFORMED A HEAD AND LINER EXCHANGE. REP PROVIDED USAGE SHEET FROM PRIOR SURGERY (REVISION OF A COMPETITOR HIP) AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10598500 ↗