Trident 623-00-36DRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 07613327025309), received between Jan 23, 2017 and May 26, 2025 — classified as 66 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (27 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISED A RIGHT HIP LINER AND HEAD DUE TO PATIENT DISLOCATION AS WELL AS INFECTION. HE REVISED TO A CONSTRAINED LINER.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 22084290 ↗
• InjuryApr 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. PROVIDED BY REP: "SPINE SURGERY YEARS AFTER THA AND STARTED DISLOCATING." A HEAD AND LINER WERE REVISED AND 2 SCREWS REMOVED (NOT REPLACED). ADDITIONAL INFORMATION RECEIVED, "LEFT SIDE. HEAD DISLOCATED FROM LINER"

  Patient problems: Joint Dislocation

  MAUDE report 19215352 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT THA ON (B)(6) 2021. PATIENT DEVELOPED PERIPROSTHETIC JOINT INFECTION AND WAS REVISED ON (B)(6) 2023. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 18795440 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS UNDER INFECTION AFTER TOTAL HIP ARTHROPLASTY. THE OPERATION DATE WAS (B)(6)2021 AND HE VISITED THE HOSPITAL AGAIN WITH INFECTION TWO MONTHS LATER. LEFT LEG. PRODUCT: STEM(ACCOLADE II),HEAD(V40 CERAMIC),INSERT(X3 POLY INSERT),CUP(TRIDENT II TRITANIUM CLUSTER),HIP SCREW(6.5 LOW PROFILE HEX).

  Patient problems: Unspecified Infection

  MAUDE report 13757912 ↗
• InjuryMar 1, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  PATIENT HAD RIGHT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH INSTABILITY AND RECURRENT DISLOCATION. UNDERGOES REVISION ON (B)(6) 2021 DUE TO LATERAL INSTABILITY ALTHOUGH WELL FIXED CUP. THE CUP, HEAD, AND LINER ARE EXCHANGED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13640474 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD LEFT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH PAIN AND PJI. UNDERGOES REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 12817733 ↗
• InjuryNov 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD RIGHT INDEX THA IN (B)(6) 2020. PATIENT PRESENTS WITH PAIN AND POSSIBLE PJI. UNDERGOES REVISION ON (B)(6) 2021. ONLY HEAD AND LINER ARE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 12808421 ↗
• InjuryNov 7, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. ORIGINAL REASON FOR REVISION WAS DISSOCIATION OF THE LINER FROM THE SHELL. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: DEFORMATION OF THE LINER, METALLOSIS DUE TO IMPINGEMENT OF THE STEM ON THE SHELL, AND THE SURGEON REPORTED THE STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY (REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL STEM'S ACTUAL VS. REPORTED SIZE). THE STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 12756284 ↗
• InjurySep 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "LEFT TOTAL HIP REVISION...DIAGNOSIS: LEFT HIP RECURRENT DISLOCATION (OF THE HEAD OUT OF THE LINER)." SPOKE TO REP, WHO PROVIDED USAGE FOR THE PRIMARY AND SUBSEQUENT REVISIONS. A FEMORAL HEAD IMPLANTED (B)(6) 2019 (REVISION REPORTED) AND LINER IMPLANTED (B)(6) 2017 WERE REVISED TO A FEMORAL HEAD WITH MDM METAL LINER AND MDM X3 INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 12419525 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR HEMATOMA. THE PATIENT STATED SHE HAD A RIGHT THA DONE (B)(6) 2007. PATIENT STARTED TO EXPERIENCE PAIN APPROX IN 2011. IN (B)(6) 2020 PATIENT HAD AN MRI AND BLOOD WORK DONE WHICH SHOWED SHE HAD HIGH COBALT LEVELS AND MRI SHOWED LARGE PSEUDOTUMORS. THE PATIENT WAS REVISED ON (B)(6) 2020. AFTER REVISION THE PATIENT EXPERIENCED A LARGE HEMATOMA ON HER RIGHT HIP. THE PATIENT STATED THE HEMATOMA WAS DRAINED THREE TIMES BUT IT KEEPS COMING BACK. THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2021 TO REMOVE THE HEMATOMA, ANY PRESENT METALS AND PUT A DRAIN FOR ABOUT 5 DAYS. PATIENT IS SEEKING COMPENSATION.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 11472687 ↗
• MalfunctionJan 14, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A MAKO THA, THE LINER WOULD NOT LOCK INTO THE TRIDENT II 48MM SHELL. THE LINER WAS REMOVED AND A SECOND LINER (SAME CATALOG #, DIFFERENT LOT) ALSO WOULD NOT LOCK INTO THE SHELL. SURGEON DECIDED TO IMPLANT AN MDM METAL LINER AND ADM/ MDM POLY INSERT INSTEAD, AND ALSO 'DOWN-SIZED' THE STEM TO ACCOMMODATE. THE FIRST 2 LINERS WERE FROM LOANERS. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES. THE STEM NEEDED TO BE CHANGED BECAUSE WE WERE GOING TO USE A 4; WHICH IS A 35MM NECK. HE WAS GOING TO USE A 36MM MINUS HEAD BUT SINCE THE 36MM LINERS WOULD NOT LOCK IN, HE HAD TO DROP DOWN TO A 3 STEM WHICH IS 5MM LESS NECK LENGTH AND USE A PLUS HEAD OPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168823 ↗
• MalfunctionJan 14, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A MAKO THA, THE LINER WOULD NOT LOCK INTO THE TRIDENT II 48MM SHELL. THE LINER WAS REMOVED AND A SECOND LINER (SAME CATALOG #, DIFFERENT LOT) ALSO WOULD NOT LOCK INTO THE SHELL. SURGEON DECIDED TO IMPLANT AN MDM METAL LINER AND ADM/ MDM POLY INSERT INSTEAD, AND ALSO 'DOWN-SIZED' THE STEM TO ACCOMMODATE. THE FIRST 2 LINERS WERE FROM LOANERS. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES. THE STEM NEEDED TO BE CHANGED BECAUSE WE WERE GOING TO USE A 4; WHICH IS A 35MM NECK. HE WAS GOING TO USE A 36MM MINUS HEAD BUT SINCE THE 36MM LINERS WOULD NOT LOCK IN, HE HAD TO DROP DOWN TO A 3 STEM WHICH IS 5MM LESS NECK LENGTH AND USE A PLUS HEAD OPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168822 ↗
• MalfunctionJan 12, 2021Noise, Audible; Noise, Audible

  AS REPORTED: "UPON STUDY MONITOR REVIEW, (B)(6) 2020 CLINIC NOTES INDICATE THE SUBJECT NOTICES "PAINLESS CLUNKING SOUND AT RIGHT HIP WITH EXERCISE, WHICH SHE HAS HAD SINCE AT LEAST (B)(6) 2020." SUBJECT IS OTHERWISE DOING FINE, REPORTING NO PAIN, NO LIMITS TO ACTIONS OF DAILY LIFE. PER THE STUDY MONITOR THE "CLUNKING" WAS NOT ADDRESSED FURTHER/DID NOT REQUIRE TREATMENT".

  Patient problems: No Information

  MAUDE report 11156681 ↗
• InjuryJan 4, 2021Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2019. PATIENT UNDERWENT REVISION LEFT TOTAL HIP ARTHROPLASTY ON THE LEFT SIDE, BOTH COMPONENTS CHANGED FOR CLOSURE OF DEHISCED LEFT HIP SURGICAL WOUND ON 1/3/2020. THE PATIENT WAS HAVING INSTABILITY SO UNDERWENT A SECOND REVISION ON (B)(6) 2020. ONLY THE LINER AND THE HEAD WERE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 11107245 ↗
• MalfunctionDec 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO GET A TRIDENT X3 36MM 0* D LINER SEATED INTO A 46MM TRIDENT PSL SHELL DURING A PRIMARY TOTALLY HIP SURGERY. ALTERNATIVELY, A TRIDENT X3 32 MM 0* D LINER WAS SEATED INTO THE SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10990432 ↗
• InjuryOct 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. PERFORMED AN I&D WITH LINER EXCHANGE FOR A LEFT HIP ORIGINALLY DONE ON 01/01/2020 DUE TO INFECTION. SURGEON FEELS RELATED TO PATIENT CONTRACTING LYME DISEASE.

  Patient problems: Unspecified Infection

  MAUDE report 10709946 ↗
• InjurySep 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "INFECTED TOTAL LEFT HIP. PLACED TEMPORARY ANTIBIOTIC HIP SPACER." UPDATE: "THE FEMORAL HEAD AND STEM WERE NOT STRYKER BRAND . THEY WERE A COMPETITIVE BRAND." UPDATE: AS REPORTED IN MEDWATCH 2302300000-2020-8005: PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY [MANUFACTURER NOT REPORTED] AND WAS DISCHARGED HOME WITHOUT COMPLICATIONS. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH A FRACTURED LEFT FEMUR AROUND HER PREVIOUS THA. SHE WAS TAKEN TO THE OR FOR REVISION OF HER LEFT FEMORAL COMPONENT WITH ORIF OF PROXIMAL FEMUR. DURING THE SURGERY, A CABLE WOULD NOT THREAD THROUGH SINGLE-SIDED TENSIONER SO THE STAFF REMOVED IT FROM SERVICE AND USED THE SECOND ONE IN THE TRAY. THAT TENSIONER WOULD ALLOW FOR A CABLE TO PASS AND SURGERY WAS COMPLETED. TWO DAYS LATER, THE CENTRAL STERILE SUPPLY MANAGER WAS EVALUATING THE "BROKEN" TENSIONER ONLY TO FIND IT WAS NOT BROKEN AT ALL BUT WAS FULL OF DEBRIS FROM PREVIOUS PATIENTS. HE THEN DISASSEMBLED THE "USED" TENSIONER TO FIND IT WAS FULL OF DEBRIS AS WELL. WE SENT OFF FOR LOANER REPLACEMENT FROM THE COMPANY AND THOSE RECEIVED, UNDER VIDEO INSPECTION, WERE FOUND TO BE CAKED WITH DEBRIS TOO. THESE DEVICES ARE DIFFICULT TO CLEAN AND VIS

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10507695 ↗
• InjuryAug 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2020. PATIENT WAS DIAGNOSED WITH A DVT RECEIVED ANTICOAGULATION AND DEVELOPED A HEMATOMA, UNDERWENT RIGHT TOTAL HIP REVISION (B)(6) 2020. HEAD AND POLY EXCHANGED. REPORTED IN CORS PER 8714HIP. PATIENT HAD A SECOND DEBRIDEMENT AND IRRIGATION ON (B)(6) 2020. HEAD AND POLY EXCHANGED AGAIN.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10459225 ↗
• InjuryAug 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2020. PATIENT WAS DIAGNOSED WITH A DVT RECEIVED ANTICOAGULATION AND DEVELOPED A HEMATOMA, UNDERWENT RIGHT TOTAL HIP REVISION (B)(6) 2020. HEAD AND POLY EXCHANGED. REPORTED IN CORS PER 8714HIP (PI (B)(4)). PATIENT HAD A SECOND DEBRIDEMENT AND IRRIGATION ON (B)(6) 2020. HEAD AND POLY EXCHANGED AGAIN. REPORTED ON CORS PER 8714HIP(2) (PI (B)(4)). PATIENT THEN HAD INFECTION OF RIGHT HIP, THEN UNDERWENT REVISION RIGHT TOTAL HIP REVISION, ALL COMPONENTS REMOVED ON (B)(6) 2020 WITH INSERTION OF OFF-LABEL ANTIBIOTIC LOADED SPACER.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10458099 ↗
• InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2020. PATIENT WAS DIAGNOSED WITH A DVT RECEIVED ANTICUAGULATION AND DEVELOPED A HEMATOMA, UNDERWENT RIGHT TOTAL HIP REVISION (B)(6) 2020. HEAD AND POLY EXCHANGED.

  Patient problems: Hematoma; Injury

  MAUDE report 10458027 ↗
• InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2019. PATIENT UNDERWENT REVISION LEFT TOTAL HIP ARTHROPLASTY ON THE LEFT SIDE, BOTH COMPONENTS CHANGED FOR CLOSURE OF DEHISCED LEFT HIP SURGICAL WOUND (B)(6) 2020.

  Patient problems: Injury

  MAUDE report 10458025 ↗
• InjuryJul 3, 2020Material Erosion; Pitted; Unstable; Unintended Movement; Material Erosion; Pitted; Unstable; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUBSIDENCE OF THE FEMORAL STEM AFTER A PATIENT FALL. SURGEON REPORTED THAT THE IMPLANTED STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY AND THAT THE FALL CONTRIBUTED TO SUBSIDENCE. DURING THE REVISION, PITTING WAS NOTED ON THE INNER ARTICULAR SURFACE OF THE POLY LINER. THE SURGEON REPORTED THIS WAS LIKELY CAUSED BY ABRASIVE MATERIAL ON THE FEMORAL HEAD, AND WOULD LIKE THE LINER TO BE INVESTIGATED TO CONFIRM, AND WOULD LIKE THE RESULTS. THE STEM, HEAD, AND LINER WERE REVISED. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Injury; Pain

  MAUDE report 10229280 ↗
• InjuryJun 25, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED HIS SUSPICION THAT THE PROXIMAL CONE BODY WAS PROBABLY NOT FULLY SEATED DURING THE PRIMARY IMPLANTATION. THE PROXIMAL CONE BODY, BIOLOX CERAMIC HEAD, AND 36D 0° INSERT WERE REVISED TO A PROXIMAL CONE BODY, LFIT V40 HEAD, SIZE D CONSTRAINED INSERT, AND A DALL-MILES GRIP PLATE WITH CABLES. REP PROVIDED USAGE SHEETS FOR THE PRIMARY AND REVISION SURGERIES, PICTURES OF THE EXPLANTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10194099 ↗
• InjuryJan 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED STATING HE HAD A LEFT HIP REPLACEMENT DONE AND WOULD LIKE TO KNOW IF HIS IMPLANTS WERE INVOLVED IN A RECALL. PATIENT IS ASYMPTOMATIC. UPDATE 20-DEC-2019: SPOKE TO PATIENT AND HE STATED HE IS EXPERIENCING PAIN AND FEELS LIKE HIS HIP GIVES OUT AS HE WALKS.

  Patient problems: Pain

  MAUDE report 9603200 ↗
• InjuryJan 9, 2020Unstable; Unstable

  AS REPORTED: "REVISION LEFT TOTAL HIP (ANTERIOR) ACETABULAR ONLY PRE-OP DIAGNOSIS: FAILED TOTAL HIP, COMPLICATION OF TOTAL HIP IMPLANT. PATIENT COMPLAINTS: DULL PAIN, FEELS LIKE HIP IS GOING TO GIVE OUT. REMOVED HEAD, LINER, 20 SCREW, 25 SCREW. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."

  Patient problems: Injury; Pain

  MAUDE report 9568084 ↗