X3 1236-2-854Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04546540639004), received between Apr 20, 2017 and May 15, 2024 — classified as 27 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LINER/HEAD AND PERFORMED AN I&D ON A LEFT HIP THAT WAS ORIGINALLY REVISED ON (B)(6) 2023 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19326058 ↗
• InjuryMay 1, 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. PATIENT ORIGINALLY PRESENTED WITH REPORT OF KNEE PAIN (PATIENT DOES NOT HAVE ANY KNEE IMPLANTS). X-RAYS SHOWED THAT THE COMPETITOR FEMORAL HEAD HAD BROKEN INTO MULTIPLE PIECES. AS A RESULT, THE TRUNNION OF THE COMPETITOR STEM WORE THROUGH THE STRYKER ADM/ MDM POLY INSERT, AND WAS ARTICULATING AGAINST THE MDM METAL LINER. THIS CAUSED THE PATIENT TO COMPENSATE THEIR GAIT, WHICH CAUSED THE KNEE PAIN. THE MDM LINER, ADM/ MDM POLY INSERT, AND COMPETITOR CERAMIC HEAD WERE REVISED TO ANOTHER MDM METAL LINER, ADM/ MDM POLY INSERT, AND COMPETITOR FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19220479 ↗
• InjuryJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "LEFT TOTAL HIP REVISION DONE TODAY DUE TO DISLOCATION SECONDARY TO FALL. IT WAS DISCOVERED THAT THE METAL HEAD HAD DISASSOCIATED FROM THE PLASTIC MDM LINER. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Fall

  MAUDE report 17303343 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16937415 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT COMPLETED 10-YEAR VISIT ON (B)(6) 2022 AT THE DOCTOR'S OFFICE. SUBJECT COMPLETED ALL EVALUATIONS. FOLLOW-UP QUESTIONNAIRE QUESTIONS ANSWERED "YES" TO HIP PAIN AND ANSWERED "NO" TO SATISFACTION OF HIP REPLACEMENT. SUBJECT FEELS PAIN WHEN WALKING. DESCRIBES THE PAIN AS A BURNING SENSATION, AS IF THE HIP IS "ON FIRE", AND RATES PAIN 9 OUT OF 10. ALSO FEELS NUMBNESS AFTER WALKING FARTHER THAN A FEW BLOCKS. PATIENT HAS BEEN FEELING PAIN AND NUMBNESS SINCE HIS SURGERY. THE DOCTOR HAS ATTRIBUTED ORIGIN OF PAIN TO THE SPINE, REFERRED PATIENT TO PHYSIATRY.

  Patient problems: Numbness; Pain

  MAUDE report 16289303 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15968177 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RIGHT HIP REVISION DUE TO ACUTE PERIPROSTHETIC JOINT INFECTION. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 15555948 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY THA ON (B)(6) 2021. THE PATIENT DEVELOPED AN INFECTION OF THE RIGHT HIP AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 15307910 ↗
• InjuryJun 27, 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 CERAMIC FEMORAL HEAD FROM THE ADM/ MDM POLY INSERT. INDEX SURGEON BELIEVED THE PATIENT HAD FALLEN, BUT X-RAYS TAKEN PRIOR TO REVISION DID NOT APPEAR TO SHOW SIGNS OF DISSOCIATION. THE HEAD AND INSERT WERE REVISED TO A METAL HEAD AND ANOTHER ADM/ MDM POLY INSERT.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 14838107 ↗
• InjuryJan 20, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: PATIENT HAD SURGERY ON THE 22ND OF DECEMBER FOR CAPUT NECROSES. HAD TRAUMATIC FALL ON THE 24TH OF DECEMBER. XRAY DISCOVERED LUXATION. REVISION SURGERY PLANNED.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 13311635 ↗
• InjurySep 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PT. PRESENTED WITH A DRAINING SURGICAL-WOUND, FOLLOWING A [RIGHT] HIP REVISION [OF COMPETITOR DEVICES] A COUPLE WEEKS AGO. DR...PERFORMED AN I&D AND SWAPPED OUT SOME COMPONENTS AS PER HIS I&D/REVISION PROTOCOL. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS THEMSELVES." SPOKE TO REP: INFECTION WAS SUSPECTED. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12514089 ↗
• InjuryApr 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PT. PRESENTED TO THE ED WITH A DRAINING SURGICAL-WOUND. PREVIOUS SURGERY WAS A [RIGHT] HIP-REVISION ON (B)(6) 2021. SURGEON FOUND THE DRAINAGE WAS STEMMING FROM A TRACT THAT LEAD DOWN TO THE JOINT. SURGEON SWAPPED OUT THE BIOLOX FEMORAL-HEAD AND MDM COMPONENTS AS PART OF HIS I&D PROTOCOL. ALSO, THE DALL-MILES TROCH PLATE AND DALL-MILES CABLES WERE REMOVED." SPOKE TO REP: INFECTION IS NOT SUSPECTED.

  Patient problems: Wound Dehiscence

  MAUDE report 11675057 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: PATIENT UNDERWENT INDEX THA ON (B)(6) 2020. THEN THE PATIENT HAD A PERIPROSTHETIC JOINT INFECTION, SO ALL COMPONENTS WHERE EXCHANGED IN A ONE STAGE REVISION ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 11059922 ↗
• InjuryNov 6, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CERAMIC FEMORAL HEAD FROM THE ADM/MDM POLY INSERT. THE CERAMIC HEAD, POLY INSERT, AND MDM METAL LINER WERE REVISED. REP CAN PROVIDE PICTURES AND THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 10800229 ↗
• InjuryOct 23, 2020Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration

  THIS PI IS FOR REVISION1. I HAD THA REVISION SURGERY ON (B)(6) 2018. THE STEM WAS REPLACED WITH A STRYKER RESTORATION MODULAR ONE. THE 28 MM CERAMIC FEMORAL HEAD WAS REPLACED WITH A COCR HEAD. HIP, GROIN, AND THIGH PAIN CONTINUED. ON (B)(6) 2019, I WAS DIAGNOSED WITH A STRESS FRACTURE AT THE TIP OF THE PROSTHETIC STEM. ON (B)(6) 2020, I HAD A BONE GRAFT TO REPAIR THE FRACTURE. A CLOUDY MILKY YELLOW FLUID ALONG WITH METAL DEBRIS WAS DISCOVERED IN THE HIP JOINT. ALSO, THERE WAS OSTEOLYSIS IN THE PROXIMAL FEMORAL FEMUR. THE ACETABULAR HAD OVERHANGING SCAR TISSUE AND BONE. THE TRUNION HAD STRIPE WEAR INDICATING IMPINGEMENT AND LIKELY SOURCE OF THE METALLOSIS. THE 28 MM FEMORAL HEAD WAS REPLACED WITH A 40MM COCR HEAD. SYMPTOMS OF METALLOSIS CONTINUE. FDA SAFETY REPORT ID# (B)(4) UPDATE: AS PER THE PATIENT, HE HAD A LEFT THA ON (B)(6) 2016. HE STARTED TO EXPERIENCE PAIN AT THE END OF (B)(6) 2016. THE PATIENT HAD A BONE SCAN DON ON (B)(6) 2017 (APPROX.) WHICH INDICATED INFECTION/IMPLANT LOOSENING. NO TREATMENT WAS GIVEN TO THE PATIENT. ON (B)(6) 2017 (APPROX.) HE WAS PLACED ON ORAL ANTIBIOTICS FOR 30 DAYS DUE TO INFECTION. ON (B)(6) 2017 X-RAYS CONFIRMED LOOSENING AND THE PATIENT WAS REVI

  Patient problems: Hip Fracture; Inadequate Osseointegration; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 10731033 ↗
• InjuryDec 2, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. AN MDM/ ADM LINER CONSTRUCT AND 28 +4 BIOLOX HEAD WERE REVISED TO A CONSTRAINED LINER AND ANOTHER FEMORAL HEAD. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9394586 ↗
• InjuryOct 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISASSOCIATION OF THE 28 +4 LFIT HEAD FROM THE ADM POLY INSERT. PATIENT REPORTED HE HAD SLIPPED AND CAUGHT HIMSELF ON A RAILING WITHOUT FULLY FALLING. THE SURGEON WAS NOT CERTAIN IF THE DISASSOCIATION CAUSED THE SLIP OR VICE VERSA. AFTER A FAILED CLOSED REDUCTION OF THE PATIENT'S HIP, THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED FOR DEVICES OF THE SAME CATALOG NUMBERS, WITH THE EXCEPTION OF A 20MM SCREW BEING REVISED TO TWO 25MM SCREWS AS THE SURGEON WAS NOT SURE IF THE SHELL WAS TOO VERTICAL. THE STEM WAS REVISED SOLELY TO GAIN ACCESS TO THE SHELL, THERE ARE NO ALLEGATIONS AGAINST ANY OF THE OTHER REVISED DEVICES. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. THE REP REPORTED HE MAY BE ABLE TO GET PRE-REVISION X-RAYS AND POSSIBLY THE PRIMARY OPERATIVE REPORT, AND CONFIRMED THAT NO OTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9255132 ↗
• InjurySep 5, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO WEAR OF THE METAL FEMORAL HEAD. SURGEON REPORTED THAT HE SUSPECTED THAT CERAMIC SHARDS REMAINED IN THE PATIENT FROM A 2016 REVISION (PI 1232546) WHICH CONTRIBUTED TO THE WEAR. BLACK TISSUE WAS NOTED INTRA-OPERATIVELY. THE PATIENT'S MDM/ ADM LINER CONSTRUCT AND 28 +4 LFIT FEMORAL HEAD WERE REVISED TO A 44G LINER AND 44MM BIOLOX HEAD WITH +4 SLEEVE. REP PROVIDED INTRA-OPERATIVE PICTURES, EXPLANT PICTURES, AND THE REVISION USAGE SHEET. THE REP MAY BE ABLE TO OBTAIN ADDITIONAL INFORMATION, BUT THE EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Injury; Osteolysis

  MAUDE report 8965840 ↗
• InjuryJun 18, 2019Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  THE CLINIC REPORTED THE FOLLOWING EVENT : " INTRAPROSTHETIC DISLOCATION BETWEEN 28 MM METAL HEAD AND PE 54/28 INSERT. EQUIPMENT IMPLANTED IN (B)(6) 2017. WEAR OF THE METAL HEAD. IT WAS FURTHER REPORTED: SENSATION OF DISLOCATION. CLINICAL + METALLOSIS PER OP BY HEAD WEAR. OBLIGATION TO CHANGE METAL BACK => REMOVAL AND RETURN.

  Patient problems: Injury; Joint Dislocation; Reaction

  MAUDE report 8707788 ↗
• InjuryMay 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MDM INSERT AND HEAD DISASSOCIATED REQUIRING REVISION.

  Patient problems: Injury

  MAUDE report 8627590 ↗
• InjuryMay 13, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO THE CERAMIC HEAD BEING FRACTURED. ADDITIONALLY, THE POLY INSERT WAS FOUND TO BE DAMAGED INSIDE. THE 48G ADM/MDM INSERT AND 28 -4 BIOLOX DELTA HEAD WERE REVISED AND THE PATIENT IRRIGATED TO ENSURE ALL PIECES WERE REMOVED. PATIENT WAS REVISED TO A 28 -4 METAL HEAD AND 48G ADM/MDM INSERT. REP PROVIDED A PRE-REVISION X-RAY, PRIMARY AND REVISION IMPLANT SHEETS, AND A PICTURE OF THE EXPLANTS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8603317 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: [SURGEON] REMOVED MDM LINER AND INSERT FROM PATIENT. REPLACED WITH A STRYKER TRIDENT X3 10° POLY INSERT". SPOKE TO REP. PATIENT WAS REVISED DUE TO SUSPECTED INFECTION AND SUSPECTED METALLOSIS (INFECTION AND METALLOSIS SUSPICIONS REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED/ IDENTIFIED). REP PROVIDED EXPLANT PICTURES SHOWING THE MDM/ ADM LINER CONSTRUCT AND COMPETITOR CERAMIC HEAD EXPLANTED (REP CONFIRMED THE HEAD WAS A COMPETITOR HEAD).

  Patient problems: Injury; Reaction; Unspecified Infection

  MAUDE report 8266674 ↗
• InjuryNov 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A REVISION FOR DISLOCATION BY ANOTHER SURGEON ON (B)(6) 2014. IMPLANTS WERE CHANGED TO AN MDM HEAD AND LINER. PATIENT DID WELL UNTIL RECENTLY WHEN HE DISLOCATED MULTIPLE TIMES. HE WAS CONVERTED TO A CONSTRAINED LINER. SURGEON NOTED 28 HEAD TO BE DISSOCIATED FROM THE MDM HEAD. ALL OTHER IMPLANTS WERE WELL FIXED AND FUNCTIONING AS EXPECTED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8047763 ↗
• InjuryJun 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT PRESENTED TO ER WITH DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED AND THE LINER CAME OUT OF THE SOCKET. PATIENT WAS REVISED TO DIFFERENT SIZES OF THE SAME DEVICES.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7581908 ↗
• InjuryJun 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT PRESENTED TO ER WITH DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED AND THE LINER CAME OUT OF THE SOCKET. PATIENT WAS REVISED TO DIFFERENT SIZES OF THE SAME DEVICES.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7580160 ↗