X3 1236-2-244Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04546540665898), received between Feb 10, 2017 and Jul 11, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K103233); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PATIENT WAS GETTING DRESSED AND HER LEG CAUGHT IN HER PANTS AND SHE FELL ON SUNDAY 15 JUNE DISLOCATING HER HIP. THEY TRIED TO RELOCATE IN EMERGENCY.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22485381 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON BOOKED PATIENT FOR HIP REVISION FOLLOWING SUSPECTED HIP INFECTION. 2X OLD COMPONENTS EXPLANTED, AND 2X REPLACEMENT ITEMS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17709496 ↗
• InjuryApr 17, 2023Unstable; Unstable

  PATIENT STATED SHE IS EXPERIENCING INSTABILITY WITH HER LEFT HIP. PRIMARY POSTERIOR LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2017 AND PATIENT HAS HAD INSTABILITY ISSUES SINCE THE SURGERY. PATIENT IS SCHEDULED FOR A LEFT HIP REVISION ON (B)(6) 2023. PATIENT STATED SHE EXPERIENCED A FALL IN 2021 IN WHICH SHE "TORE" HER LEFT HAMSTRING AND EXPERIENCED MILD EDEMA HOWEVER A DISLOCATION WAS RULED OUT VIA XRAY. PATIENT INQUIRING IF PRODUCTS ARE SUBJECT TO RECALL. UPDATE: PATIENT CONFIRMED A LEFT HIP REVISION PERFORMED ON (B)(6) 23. "THEY DID REPLACE MY CUP, LINER AND BALL BUT THAT¿S ALL I KNOW THIS FAR."

  Patient problems: Fall; Joint Laxity

  MAUDE report 16758765 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I&D AND REPLACEMENT OF ALL PARTS EXCEPT THE CUP OF A LEFT TOTAL HIP. THE STEM, HEAD AND MDM LINER WERE REPLACED. NO ALLEGATIONS MADE AGAINST THE IMPLANTS." REP CONFIRMED THAT THIS REVISION WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14266043 ↗
• InjurySep 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT IS FOR THE REVISION ON (B)(6) 2021. WHILE REPORTING A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2021 DUE TO "22MM INNER HEAD HAD DISASSOCIATED FROM THE POLYETHYLENE INSERT," THE SURGEON REPORTED THAT THE PATIENT HAD A PRIOR REVISION ON (B)(6) 2021 FOR THE SAME REASON. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12482809 ↗
• InjurySep 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE 22MM INNER HEAD HAD DISASSOCIATED FROM THE POLYETHYLENE INSERT. THERE IS NO FURTHER INFORMATION AVAILABLE." LEFT HIP. PATIENT WAS REVISED FROM AN MDM X3 INSERT AND LFIT V40 HEAD TO TRIDENT CONSTRAINED INSERT AND NEW LFIT V40 HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12482799 ↗
• InjuryDec 17, 2020Adverse 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 AFTER PATIENT COMPLAINT OF PAIN AND THE FINDING OF A POCKET OF FLUID IN THE PATIENT. INTRA-OPERATIVELY, THE FLUID WAS OBSERVED TO BE THE PATIENT'S BLOOD. FEMORAL HEAD, ADM/ MDM INSERT, AND MDM METAL LINER WERE REVISED TO A CONSTRAINED LINER AND NEW FEMORAL HEAD. REP PROVIDED AN EXCERPT OF THE ORIGINAL IMPLANT REPORT AND THE REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11027700 ↗
• InjuryAug 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY OUTSIDE CORS SCOPE. PATIENT WAS REVISED DUE TO FEMORAL LOOSENING ON (B)(6) 2019. PATIENT DEVELOPED PJI AND ALL COMPONENTS WHERE REMOVED ON (B)(6) 2020. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2020.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10458141 ↗
• InjuryJun 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. AN ACCOLADE II STEM, 22.2 +3 LFIT HEAD, MDM LINER AND POLY INSERT WERE REVISED TO COMPETITOR FEMORAL DEVICES AND 36D 0° INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Pain

  MAUDE report 10137193 ↗
• InjuryNov 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED HER LEFT HIP THA. CLOSED REDUCTION WAS NOT SUCCESSFUL AND IT WAS DECIDED TO REVISE AND CHANGE A +0 22.2MM HEAD TO A +8 22.2MM HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9372805 ↗
• InjurySep 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT IS PART OF THE TRITANIUM PRIMARY ACETABULAR SHELL STUDY AND REPORTED PAIN IN THE STUDY HIP DURING THE 6 AND 7-YEAR VISITS, RESPECTIVELY. PATIENT REPORTED RIGHT HIP PAIN AT NIGHT DURING THE 6-YEAR VISIT ((B)(6) 2017) AND CONTINUED RIGHT-HIP PAIN DURING THE 7-YEAR VISIT ((B)(6) 2018). PATIENT HAS NOT BEEN REVISED AS OF THE EVENT DATE.

  Patient problems: Pain

  MAUDE report 9087584 ↗
• InjuryJun 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE WAS A PATIENT THAT UNDERWENT A HIP REVISION THAT HAD AN ACCOLADE II STEM AND MDM HEAD. THERE WAS A 52MM TRITANIUM CUP AND A 22MM METAL HEAD IMPLANTED. UPON OPENING THE HIP, IT WAS REALIZED THAT THE 22MM HEAD DISASSOCIATED FROM THE 38D MDM POLY INSERT. UPDATE: "THIS WAS A REVISION OF THE PRIMARY STRYKER IMPLANTS" RIGHT SIDE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8672063 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE ADM/ MDM INSERT FROM THE MDM METAL LINER. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR DISLOCATION WAS REPORTED TO THE REP. THE POLY INSERT, FEMORAL HEAD AND STEM WERE REVISED TO STRYKER DEVICES (THERE ARE NO ALLEGATIONS AGAINST THE HEAD, THE SURGEON WANTED TO IMPLANT A STEM WITH A GREATER OFFSET). REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8664405 ↗
• InjuryMay 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION OF MDM POLY INSERT FROM THE MDM METAL LINER CAUSED WHEN THE PATIENT GOT UP FROM A LOW, SOFT COUCH. THE LINER CONSTRUCT AND FEMORAL HEAD WERE REVISED TO A CONSTRAINED LINER AND A FEMORAL HEAD OF THE SAME CATALOG NUMBER (THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD). REP PROVIDED IMPLANT SHEETS FROM CURRENT AND PRIOR SURGERIES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8654589 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "CUP, HEAD, LINERS REMOVED DUE TO METALLOSIS CAUSED BY MALPOSITIONED IMPLANTS RESULTING IN IMPINGEMENT".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8627319 ↗
• InjuryMay 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. (B)(6) CONTACTED US FOR A MDM LUXATED BY A PATIENT WITH A THA. THE PRIMARY SURGERY TOOK PLACE IN 2014 (EXETER STEM AND TRITANIUM SOLID CUP). THERE WAS AN ACETABULAR REVISION IN 2017. AN MDM LINER WAS PLACED. THIS WAS LUXATED. THE MDM LINER WAS REMOVED AND A CONSTRAINED LINER WAS PLACED. THE V40 22.2 / +3 HEAD WAS OUT OF DE X3 RESTORATION LINER (B)(6) 20019). ADDITIONAL PATIENT RECORDS/ X-RAYS AND OPERATION REPORTS ARE NOT AVAILABLE IN THIS CASE UPDATE 24 JULY 2019 BASED ON MEDICAL REVIEW. THIS PI RELATES TO THE SECOND REVISION SURGERY WHICH OCCURRED (B)(6) 2019 DUE TO DISLOCATION. AN X-RAY ON (B)(6) 2019, DOCUMENTED AN INTRAPROSTHETIC DISLOCATION OF THE MDM CONSTRUCT WITH MIGRATION OF THE STEM IN SUPERIOR DIRECTION. CUP SHELL AND STEM POSITION REMAIN UNCHANGED FROM PREVIOUS DESCRIPTIONS (SHELL MALPOSITION) BECAUSE RETAINED DURING REVISION SURGERY IN 2017 WITH ONLY CONVERSION OF THE BEARING IN THE TRIDENT SHELL FOR AN MDM CONSTRUCT WITH NEW V40 22-MM/+3 FEMORAL HEAD. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 WITH EXCHANGE OF THE MDM BEARING FOR A CONSTRAINED CUP INSERT SYSTEM WITH NEW V40 22- MM/+0 FEMORAL HEAD. THE NEW ARTHROPLASTY CONDITION WAS DOCUMENTED ON POST

  Patient problems: Injury

  MAUDE report 8619241 ↗
• InjuryMay 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. SURGEON REPORTED THE INFECTION WAS CONFIRMED AS E. COLI. AN MDM LINER CONSTRUCT AND 22.2 +0 V40 METAL HEAD WERE SWAPPED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8615839 ↗
• InjuryMay 13, 2019Naturally Worn; Naturally Worn

  SURGEON REPORTED THAT THERE WAS MDM POLY WEAR CAUSING SYNOVITIS. WE REMOVED THE MDM BEARING CONSTRUCT AND REPLACED IT WITH A POLY LINER, UNIVERSAL SLEEVE AND HEAD. LEFT SIDE.

  Patient problems: Injury; Synovitis

  MAUDE report 8603845 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REP REPORTED THROUGH A FAX THAT PATIENT DISLOCATED THEIR RIGHT HIP. OPEN REDUCTION OF HIP, CHANGED ADM LINER AND FEMORAL HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8565641 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR PATIENT'S REVISION ON (B)(6) 2019. PATIENT HAD PRIMARY TOTAL RIGHT HIP ARTHROPLASTY (B)(6) 2016. DOCTOR PERFORMED HIP REVISION ON (B)(6) 2018 [PI (B)(6)] AND CONVERTED TO MDM CONSTRUCT. DOCTOR SAID PATIENT WAS BENDING DOWN TO FEED DOGS AND FELT POP IN HER HIP. X-RAY SHOWED PATIENT'S HIP DISLOCATED. CLOSED REDUCTION PERFORMED. DOCTOR DECIDED TO PERFORM SECOND REVISION AND UPON EXPOSURE FOUND STEM WELL FIXED AND ALIGNED, THE 22.2MM HEAD WELL FIXED TO THE STEM BUT DISASSOCIATED FROM THE ADM X3 POLY, AND THE POLY LOOSE FROM THE MDM LINER. THE LINER WAS WELL FIXED TO THE CUP AND THE CUP WAS WELL FIXED AND WELL ALIGNED. DOCTOR STATED THAT THE DISASSOCIATION COULD HAVE HAPPENED EITHER PRIOR TO THE CLOSED REDUCTION OR DURING THE CLOSED REDUCTION. HE THEN PROCEEDED TO REMOVE 22.2 FEMORAL HEAD WITH BONE TAMP AND MALLET AND MDM LINER FROM CUP USING A OSTEOTOME AND MALLET. DOCTOR IMPLANTED A TRIDENT 0° CONSTRAINED ACETABULAR INSERT SIZE D AND 22.2 X 0 V40 FEMORAL HEAD. PATIENT HAD A SPINAL FUSION PRIOR TO INITIAL SURGERY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8319121 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  [SURGEON] REVISED AN MDM LINER/HEAD FOR AN I&D INFECTION. HE REPLACED WITH A STANDARD 36 LINER AND HEAD.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8108645 ↗
• InjuryAug 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT PRESENTED WITH A DISLOCATED HIP. HER HIP WAS REDUCED AND ASSESSED FOR STABILITY. HIP WAS DETERMINED TO BE STABLE, FEMORAL HEAD AND MDM COMPONENT WERE SWAPPED OUT [NO CHANGES TO SIZE OR LENGTH] AS PART OF SURGEON'S 'IRRIGATION AND DEBRIDEMENT' PROTOCOL".

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7826355 ↗
• InjuryJun 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT HIP REVISION FOR INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7567132 ↗
• InjuryMay 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. AN MDM LINER CONSTRUCT AND FEMORAL HEAD WERE REVISED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7532758 ↗
• InjuryApr 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT'S HIP (SIDE NOT REPORTED) WAS REVISED AFTER A REVIEW OF X-RAYS SHOWED THE INSERT SELECTED AND IMPLANTED THE DAY PREVIOUSLY WAS NOT THE CORRECT SIZE FOR THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7442544 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103233. One submission often covers many models, so check the product and lot details in each record.

• Z-0192-2012 · Jun 3, 2011 · Terminated
  Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av d