X3 1236-2-848Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 04546540638977), received between Mar 9, 2017 and Jan 16, 2026 — classified as 109 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (53 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 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: THIS PI IS FOR THE 2024 REVISION. PATIENT HAD A RIGHT PRIMARY THA OUTSIDE OF CORS SCOPE. PATIENT HAD MECHANICAL FAILURE WITH METALLOSIS AT THE TRUNNION, WAS REVISED ON (B)(6) 2016. (ENTERED CORS). ALL COMPONENTS WERE EXCHANGED EXCEPT CUP. PATIENT PRESENTED INSTABILITY, HAD 2ND REVISION ON (B)(6) 2024, WITH OFF-LABEL COMPONENTS. CUP, MDM COMPONENTS, SLEEVE AND HEAD WERE EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24097111 ↗
• InjuryApr 1, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PATIENT HAD A REVISION DUE TO DISLOCATION AND SUSPECTED HEAD DISSOCIATION.

  Patient problems: Joint Dislocation

  MAUDE report 21738771 ↗
• InjuryFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION OF RIGHT TOTAL HIP DUE TO DISLOCATION (MDM POLY HEAD WAS DISASSOCIATED FROM V-40 FEMORAL HEAD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460305 ↗
• InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY FOR B/N 11603361ORIGINAL SURGERY IN 2022 FOR A TOTAL HIP REPLACEMENT. MDM CONSTRUCT HAS SEEMED TO HAVE FAILED AND THE INNER HEAD HAS DISSOCIATED FROM THE OUTER POLY. REQUIRED REVISION SURGERY TO REPLACE HEAD, LINER AND INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 21402935 ↗
• InjuryAug 15, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REVISION OF MDM ON EXETER TRIDENT.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 19992308 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. REPORTED VIA PHONE THAT; THEY NEED SOME INFORMATION ON THESE PRODUCTS, ON THESE IMPLANTS WHICH WAS RECALLED. I JUST HAD A REVISION SURGERY. 2016 HAD DISCOMFORT, AND PAIN IN THE HIP WHICH WAS DIAGNOSED AS A PINCHED NERVE AND RECEIVED CORTISONE SHOTS FOR IT. SCARRED TISSUE WAS NOTICED DURING REVISION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain; Scar Tissue

  MAUDE report 19992131 ↗
• InjuryJul 26, 2024Unstable; Unstable

  THIS PI IS FOR CLOSED REDUCTION ON (B)(6) 2023. PATIENT HAD AN INDEX LEFT CONVERSION THA ON (B)(6) 2020. THE PATIENT THEN DISLOCATED THE LEFT HIP, A CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2023. PATIENT CONTINUED WITH INSTABILITY AND AN OPEN REDUCTION WITH A CONSTRAINED LINER AND HEAD EXCHANGE WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Joint Laxity

  MAUDE report 19836771 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS DESCRIBED BY PATIENT: "I AM WRITING TO ENQUIRE IF YOU COULD PLEASE KINDLY CONFIRM WHETHER AN AGREEMENT WAS IN PLACE FOR THE USE OF THE STRYKER HIP IMPLANT COMPONENTS OUTLINED BELOW TO BE USED IN COMBINATION WITH THE ¿EMBODY¿ CEMENTLESS ACETABULAR CUP WITHIN THE PERIOD OF (B)(6) 2017 AND (B)(6) 2018. " UPDATE: I AM AWAITING MY 2ND REVISION SURGERY ON THE SAME HIP (AS HAVE HAD PROBLEMS FROM THE OUTSET WHICH HAVE SUBSTANTIALLY WORSENED IN THE PAST YEAR), AND DO NOT HAVE A FIXED DATE YET, THOUGH IT WILL BE 'SOON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19168759 ↗
• InjuryMar 28, 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 FEMORAL PERIPROSTHETIC FRACTURE. A COMPETITOR STEM AND HEAD, AND A STRYKER LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 18994021 ↗
• InjuryAug 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: REVISION SURGERY TODAY OF A LEFT TOTAL HIP. THE REVISION TODAY WAS SECONDARY TO DISLOCATION. THE DISLOCATION (DISASSOCIATION) OCCURRED BETWEEN THE CERAMIC HEAD AND POLY INSERT. THE MDM LINER, INSERT, HEAD AND CUP WERE REMOVED. A NEW CUP WAS PLACED WITH FOUR SCREWS, A CONSTRAINED LINER AND NEW HEAD. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL." SURGEON FELT THAT THE SHELL POSITION WAS TOO VERTICAL, AND REVISED THE SHELL AND A SCREW.

  Patient problems: Joint Dislocation

  MAUDE report 17648751 ↗
• InjuryAug 10, 2023Unstable; Unstable

  PATIENT HAD AN INDEX LEFT THA OUTSIDE OF CORS SCOPE. PATIENT HAD ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND MALUNION OF A FEMORAL PERIPROSTHETIC FRACTURE. THE PATIENT WAS REVISED ON (B)(6)2020. NOW THE PATIENT COMPLAINS OF PAIN AND IS DIAGNOSED WITH CHRONIC INSTABILITY. THE PATIENT UNDERGOES REVISION ON (B)(6)2022. THE PROXIMAL FEMORAL REPLACEMENT AND THE MDM COMPONENTS WERE EXCHANGED. THE ACETABULAR CUP AND OTHER COMPONENTS OF THE PROXIMAL FEMORAL COMPONENT (EXTENSION PIECE AND STEM) WERE RETAINED. THE PATIENT WAS STABILIZED WITH A CONSTRAINED LINER.

  Patient problems: Joint Dislocation; Muscle Weakness/Atrophy; Pain; Paralysis

  MAUDE report 17495862 ↗
• InjuryMay 19, 2023Degraded; Device Dislodged or Dislocated; Naturally Worn; Degraded; Device Dislodged or Dislocated; Naturally Worn

  THIS PI IS EVENT 2. SECOND REVISION SURGERY ON (B)(6) 2023. BONE HEAD CENTER POSITION WAS OBVIOUSLY WRONG ON THE RELINE AND THE SLIDING SURFACE WAS MOVING STRANGELY. SURGEON FOUND THAT THE ADM INSERT WAS DEFORMED/WORN DURING SURGERY. FINISHED THE REVISION SURGERY WITH COMPETITOR DEVICE ON (B)(6) 2023.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 16961099 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR DIAGNOSIS OF RIGHT DISTAL LOWER EXTREMITY DVT ON AUGUST 14, 2019 AND ONGOING TREATMENT FOR CONTINUED PAIN AND NEUROPATHIC SYMPTOMS BELOW THE RIGHT KNEE (LOSS OF SENSATION AND FUNCTION). AS REPORTED IN MEDWATCH MW5092796: DOCTOR REPLACED BALL AND SOCKET COMPONENTS, ORIGINALLY PLACED IN 2008. RIGHT HIP. DOCTOR STATED THAT THE SCIATIC NERVE HAD BEEN TRAUMATIZED DURING THE EXTENDED PROCEDURE TO CLEAR THE DAMAGED TISSUE AND TOOK OVER TWO HOURS LONGER. THE RIGHT FOOT DID NOT RESPOND TO PHYSICAL THERAPY IN THE HOSPITAL, SO I WAS RELEASED WITH AN AFP BRACE. FURTHER, TESTIMONY AND CONTINUED DISABILITY CAUSED THE DOCTOR TO "REATTACK" THE DAMAGED RIGHT HIP FROM THE REAR ON (B)(6) 2019. DURING THIS PROCEDURE SCAR TISSUE WAS REMOVED FROM THE SHEATH ON THE NERVE MANUALLY THROUGH THE 8 INCH INCISION. ELECTRIC STIMULATOR OF THE NERVE CAUSED TOES TO MOVE. STILL TREATMENT FOR LOWER EXTREMITY BLOOD CLOTS AND FOOT SWELLING CONTINUE INTO THE SIXTH MONTH, WITH MINOR IMPROVEMENT. UPDATE (B)(6) 2020: "ADD'L INFO RECEIVED [BY FDA] ON 03/23/2020 FROM REPORTER FOR REPORT MW5093848. GENTLEMEN: THE ITEMS ARE MY WIFE'S REQUEST FOR A CLASS 1 RECALL OF STRYKER METAL-ON-METAL HIP HEAD BALL COMPONENT

  Patient problems: Ambulation or Postural Difficulties; Neuropathy; Pain; Thrombosis/Thrombus

  MAUDE report 16928817 ↗
• InjuryNov 29, 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 FEMORAL HEAD FROM THE ADM/ MDM POLY INSERT. POSSIBLE CAUSE OR CONTRIBUTOR TO DISSOCIATION NOT REPORTED TO THE REP. THE HEAD AND POLY INSERT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 15875748 ↗
• InjuryOct 6, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE INNER HEAD AND MDM INSERT WERE DISENGAGED WHEN THE PATIENT UNDERWENT AN REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 15549757 ↗
• InjurySep 5, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN MDM LINER WAS BEING REVISED DUE TO INSTABILITY. ON ENTERING THE HIP, THE SURGEON DISCOVERED THAT THE MDM INSERT AND INNER 28MM HEAD HAD BECOME DISARTICULATED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15354429 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION RIGHT TOTAL HIP ARTHROPLASTY, HEAD LINER EXCHANGE. PRE-OP DIAGNOSIS: CHRONIC PAIN. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." AN ADM/ MDM POLY INSERT AND COMPETITOR FEMORAL HEAD WERE REVISED.

  Patient problems: Pain

  MAUDE report 15205679 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE HEAD AND POLYHEAD BECAME DETACHED DURING THE REPOSITIONING OPERATION WHEN DISLOCATED. REVISION SURGERY. UPDATE (B)(6) 2022: ORIGINAL IMPLANTATION DATE WAS IN 2015.

  Patient problems: Insufficient Information

  MAUDE report 15050773 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ARTHROPLASTY TOTAL HIP REVISION - RIGHT. I&D, POLY EXCHANGE. PRE-OP DIAGNOSIS: RIGHT HIP INFECTION." AN ADM/ MDM POLY LINER AND 28 -2.7 BIOLOX HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 14691894 ↗
• InjuryApr 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED. UPON REDUCTION ATTEMPTS THE STEM LOOSENED IN CEMENT MANTLE, AND THE MDM X3 INSERT AND THE 28MM CERAMIC HEAD DISASSOCIATED.

  Patient problems: Joint Dislocation

  MAUDE report 14135735 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT EXPERIENCING PAIN IN RIGHT HIP. REVISION TOTAL HIP.

  Patient problems: Pain

  MAUDE report 14029822 ↗
• InjuryMar 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13757905 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 13691944 ↗
• InjuryJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A TOTAL HIP REVISION, IT WAS OBSERVED THAT AN MDM POLY WAS DISLODGED FROM THE INNER 28MM CERAMIC HEAD.

  Patient problems: Insufficient Information

  MAUDE report 13210437 ↗
• InjuryNov 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, IT WAS DISCOVERED THAT THE ADM/ MDM POLY LINER WAS BROKEN IN HALF, AND THE SURGEON REPORTED THAT THE LINER WAS WORN WHERE THE COLLAR OF THE METAL FEMORAL HEAD WAS ARTICULATING WITH THE POLY. A METAL MDM LINER, POLY ADM/ MDM INSERT, AND METAL FEMORAL HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12757567 ↗