X3 1236-2-852Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04546540638991), received between Apr 11, 2017 and Jan 16, 2026 — classified as 81 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (37 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAD A LEFT PRIMARY THA OUTSIDE OF CORS SCOPE. PATIENT HAD INSTABILITY, WAS REVISED ON (B)(6) 2019. (ENTERED CORS). ALL COMPONENTS WHERE EXCHANGED. PATIENT PRESENTED WITH PJI, HAD 2ND, REVISION ON (B)(6) 2024. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 24097110 ↗
• InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEFT TOTAL HIP. THE REVISION TODAY WAS SECONDARY TO A FALL IN WHICH THE CERAMIC HEAD WAS DISASSOCIATED FROM THE POLY MDM INSERT. THIS DISASSOCIATION WAS DISCOVERED PREOP ON CT. IN SURGERY IT WAS FOUND THAT THE STEM WAS IMPINGING ON THE CUP POSTERIOR SUPERIOR AND HAD CAUSED A SMALL NOTCH ON THE NECK OF THE FEMORAL IMPLANT. THE 28MM HEAD AND INSERT WERE REMOVED. A +0 HEAD SEAMED TO ELIMINATE THE IMPINGEMENT PROBLEM AND STABILIZE THE JOINT. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Fall

  MAUDE report 18957858 ↗
• InjuryMar 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "PATIENT WAS REVISED DUE TO RECURRING DISLOCATIONS." SPOKE TO REP. A COMPETITOR HEAD DISSOCIATED FROM AN ADM/ MDM POLY INSERT. REP CAN PROVIDE A PICTURE, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 18884456 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INFECTION. ON (B)(6) 2023, ALL COMPONENTS EXCEPT THE SHELL WERE REMOVED BECAUSE THE SURGEON DID NOT HAVE THE INSTRUMENTATION TO REMOVE THE SHELL. ON (B)(6) 2023, THE SHELL WILL BE REMOVED AND A SPACER PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18501057 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY THA ON (B)(6) 2022, SHE DEVELOPED PERIPROSTHETIC JOINT INFECTION. WAS REVISED WITH ALL COMPONENTS EXTRACTED ON (B)(6) 2022. A SPACER WAS PLACED AND A DALL-MILES CABLE USED FOR PROPHYLACTIC CERCLAGE AROUND THE FEMUR. ON (B)(6) 2022 THE PATIENT UNDERWENT REIMPLANTATION WITH OUT OF CORS COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 17395514 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX L THA ON (B)(6) 2021, PATIENT DEVELOPS PJI REQUIRING A LEFT THA REVISION ON (B)(6) 2022. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 16938516 ↗
• InjuryMay 9, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PATIENT WAS REVISED DUE TO DISLOCATION. THE MDM POLY HEAD HAD DISASSOCIATED FROM THE CERAMIC INNER HEAD. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." PATIENT WAS REVISED TO A CONSTRAINED LINER AND ANOTHER FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 16898720 ↗
• InjuryJan 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RIGHT TOTAL HIP DISLOCATION DUE TO PATIENT FALL. EXCHANGED MDM POLY HEAD AND V-40 FEMORAL HEAD, REDUCED HIP. PER RESPONSE: "V-40 FEMORAL HEAD CAME OUT OF ADM/MDM POLY INSERT ".

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16156333 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT THA ON (B)(6), 2021. PATIENT PRESENTED WITH PAIN AND SIGNS OF PJI. WAS REVISED ON (B)(6), 2022. ALL MDM & HEAD COMPONENTS EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15968179 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION ON (B)(6) 2022. THE PATIENT HAD A PRIMARY LEFT THA OUT OF CORS SCOPE. ON (B)(6), 2021 THE PATIENT HAS A PERIPROSTHETIC FRACTURE OF THE FEMUR AND IS ENTERED INTO CORS. THE PATIENT DEVELOPED AN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ONLY THE MDM & HEAD COMPONENTS EXCHANGED ON (B)(6), 2021. PATIENT DEVELOPS INFECTION AGAIN AND UNDERGOES REVISION ON (B)(6), 2022. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 15959063 ↗
• InjuryDec 6, 2022Use of Device Problem; Use of Device Problem

  REVISION TOTAL HIP. IT WAS NOTICED THAT A F MDM INSERT WAS PLACED WITH E MDM LINER.

  Patient problems: Insufficient Information

  MAUDE report 15922670 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: SUBJECT WAS SENT BY MAIL THE 7-YEAR FORMS TO COMPLETE. DURING MY INTERNAL REVIEW OF THE FORMS, I NOTICED WITHIN THE FOLLOW-UP QUESTIONNAIRE, THE SUBJECT ANSWERED "YES" TO THE QUESTION "DO YOU HAVE ANY PAIN IN YOUR HIP THAT HAS THE STUDY HIP REPLACEMENT". THE SUBJECT COMMENTS STATES "WHEN I AM SITTING". THE SUBJECT ANSWERED "YES" TO THE QUESTION "ARE YOU SATISFIED WITH THE RESULTS OF YOUR STUDY HIP REPLACEMENT", HOWEVER, THE SUBJECT'S COMMENT TO THE QUESTION STATES "SOME WHAT!". THERE WAS A PREVIOUSLY FILED AE FORM FOR TROCHANTERIC BURSITIS ON (B)(6) 2020 AND RESOLVED DATE WAS ON (B)(6) 2020. LISTED ON AE SUBJECT WAS TREATED WITH VOLTAREN AND IBUPROFEN. X-RAYS WERE NOT TAKEN FOR THIS VISIT. UPDATE: "RIGHT SIDE" HIP. UPDATE: MEDICAL RECORDS, OP REPORTS, PROGRESS NOTES, AND PATHOLOGY/LAB REPORTS "NOT AVAILABLE AS ENROLLED IN CLINICAL STUDY."

  Patient problems: Pain

  MAUDE report 15638261 ↗
• InjuryOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE METAL FEMORAL HEAD FROM THE ADM POLY INSERT. THE DISSOCIATED COMPONENTS WERE REVISED. UPDATE: RECEIVED MEDICAL RECORDS/OP REPORT WHICH CONFIRMED THAT A CERAMIC FEMORAL HEAD WAS USED AND NOT A METAL FEMORAL HEAD.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 15587584 ↗
• InjurySep 16, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. THE SURGEON PRIMARILY WANTED TO REVISE THE COMPETITOR STEM TO CHANGE ITS VERSION, BUT REVISED THE LINER CONSTRUCT AS WELL, PARTIALLY TO ACCESS THE FEMUR. AN MDM METAL LINER AND ADM/ MDM POLY INSERT WERE REVISED TO A CONSTRAINED LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15436366 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY THA OUT OF CORS SCOPE. ON (B)(6), 2021 THE PATIENT HAS A PERIPROSTHETIC FRACTURE OF THE FEMUR AND IS ENTERED INTO CORS. THE PATIENT DEVELOPED AN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ONLY THE MDM & HEAD COMPONENTS EXCHANGED ON (B)(6), 2021.

  Patient problems: Unspecified Infection

  MAUDE report 15307916 ↗
• InjuryJul 18, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. AN ADM/ MDM POLY INSERT, MDM METAL LINER, CERAMIC HEAD AND SLEEVE AND 2 SCREWS WERE REVISED TO A CONSTRAINED LINER AND NEW FEMORAL HEAD. REP CONFIRMED THAT INTRA-OPERATIVELY NO IMPLANTS WERE NOTED TO BE WORN, LOOSE, OR DAMAGED.

  Patient problems: Joint Laxity

  MAUDE report 15046650 ↗
• InjuryJun 20, 2022Unstable; Unstable

  PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6), 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Joint Laxity

  MAUDE report 14750392 ↗
• InjuryJun 19, 2022Degraded; Fracture; Unstable; Detachment of Device or Device Component; Degraded; Fracture; Unstable; Detachment of Device or Device Component

  AS REPORTED IN MEDWATCH: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022. ADDITIONAL INFORMATION REPORTED: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Laxity; Metal Related Pathology; Pain

  MAUDE report 14741220 ↗
• InjuryJun 16, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  I WAS IN A DEEP SQUAT, ONE I HAD DONE MANY TIMES BEFORE, AND MY IMPLANT FAILED AND SLIPPED OUT OF THE SOCKET. UPDATE PER CONVERSATION WITH PATIENT 05/25/2022: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2022, PATIENT WAS IN A "DEEP SQUAT" AND THE LEFT HIP "FELL OUT TO THE BACK". PATIENT NOTED THAT PRIOR TO REVISION, SURGEON INDICATED POTENTIAL "STEM HITTING CUP AND LINER BREAKAGE" (PATIENT IS UNSURE IF LINER WAS METAL OR POLY). PATIENT ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT. PATIENT'S LEFT HIP WAS REVISED ON 05/11/2022. PATIENT HAS NOT RETURNED TO SURGEON YET FOR FOLLOW UP AND IS UNSURE AT THIS TIME WHAT PARTS WERE REVISED. PATIENT WILL SUPPLY MEDICAL RECORDS. UPDATE 13/JUNE/2022: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 14710819 ↗
• InjuryApr 29, 2022Adverse 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. AS REPORTED: "PT. PRESENTED WITH DRAINAGE FROM HIS SURGICAL WOUND...NO CONFIRMATION OF INFECTION YET, BUT DR. OPTED TO SWAP OUT SOME COMPONENTS WHILE PERFORMING HIS USUAL I&D PROTOCOL." AN MDM METAL LINER, ADM/ MDM POLY INSERT AND CERAMIC FEMORAL HEAD WERE REVISED. REP PROVIDED USAGE SHEET FROM CURRENT AND PRIOR REVISION. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fluid Discharge

  MAUDE report 14247784 ↗
• InjuryApr 20, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  AS REPORTED: "PATIENT STATES THERE IS A LOT OF MUSCLE PAIN AROUND THE HIP AREA, USING A CANE TO WALK BUT IS LIMITED BY ANKLE PAIN AND SWELLING." CLINIC NOTES INDICATE: "LOOSENING OF HIP JOINT PROSTHESIS. MECHANICAL LOOSENING OF INTERNAL LEFT HIP PROSTHETIC JOINT. WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC."

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14160397 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOR THE REVISION ON (B)(6) 2022 DUE TO INFECTION. AS REPORTED: "INITIAL OP DATE WAS (B)(6) 2021 AND WAS REVISED ON (B)(6) 2021 FOR A PERI-PROSTHETIC FRACTURE AFTER A FALL, ON TODAY (B)(6) 2022 THE HIP WAS REVISED AGAIN DUE TO INFECTION AND ALL PARTS EXCEPT THE 155 DISTAL STEM WERE REMOVED AND REVISED." UPON REVIEW OF PATIENT HISTORY AND AFTER SPEAKING TO THE REP, THE FOLLOWING IS THE ACCURATE SURGICAL HISTORY FOR THE PATIENT: PRIMARY IMPLANTATION ON (B)(6) 2021. FIRST REVISION (B)(6) 2021 DUE TO INFECTION. REVISION (B)(6) 2021 DUE TO FEMORAL PERIPROSTHETIC FRACTURE. REVISION (B)(6) 2022 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13715300 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX RIGHT THA ON (B)(6) 2021. PATIENT PRESENTED WITH INFECTION OF RIGHT HIP. UNDERWENT REVISION FOR PJI ON (B)(6) 2021. MDM AND HEAD COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 13705789 ↗
• InjuryDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A POST-OP X-RAY TAKEN THE SAME DAY AS THE PRIMARY HIP REPLACEMENT INDICATED DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED AND FAILED, AND THE PATIENT WAS REVISED THE SAME DAY. DURING THE REVISION, THE ADM/ MDM POLY INSERT WAS FOUND FLOATING IN THE JOINT. THE 46F ADM/ MDM POLY INSERT AND 28+0 BIOLOX HEAD WERE REVISED TO ANOTHER 46F ADM/ MDM INSERT AND 28 +4 BIOLOX HEAD. INTRAOPERATIVELY, THE BIOLOX HEAD WAS STILL ATTACHED TO THE STEM TRUNNION.

  Patient problems: Joint Dislocation

  MAUDE report 13029582 ↗
• InjuryDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE FEMORAL HEAD FROM THE ADM/ MDM POLY INSERT. THE FEMORAL HEAD, POLY INSERT, AND MDM LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED METAL LINER.

  Patient problems: Insufficient Information

  MAUDE report 12910407 ↗