MDM 626-00-42ERecalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 04546540666017), received between Apr 25, 2017 and Sep 22, 2025 — classified as 71 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (36 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 75 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2025Degraded; Mechanical Problem; Degraded; Mechanical Problem

  NO NEW INFORMATION.

  Patient problems: Loss of Range of Motion; Metal Related Pathology

  MAUDE report 23106952 ↗
• InjuryMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A PRIMARY HIP REPLACEMENT WHERE AN MDM LINER, POLY INSERT, AND 28 CERAMIC HEAD WAS IMPLANTED. UPON FOLLOW UP THE LINER WAS STILL ATTACHED TO THE CUP AND THE HEAD WAS STILL ATTACHED TO THE STEM, BUT THE POLY INSERT HAD DETACHED FROM THE LINER AND HEAD AND WAS DISLODGED IN PATIENT. THE SURGEON PERFORMED A REVISION SURGERY AND REMOVED THE HEAD, LINER AND INSERT. HE REPLACED IT WITH A CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 22097127 ↗
• InjuryApr 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 21738767 ↗
• InjuryFeb 10, 2025Corroded; Degraded; Corroded; Degraded

  THE FOLLOWING WAS REPORTED: "I HAVE AN EXPLANTED MDM FROM A PATIENT. THE OPERATING SURGEON WHO REVISED IT HAS REQUESTED IT BE SENT BACK TO STRYKER FOR INVESTIGATION. PATIENT HAD PAIN AND SWELLING AT HIP, PSEUDO TUMOUR COLLECTION OF FLUID. REASON FOR REVISION: PAIN AND SWELLING SECONDARY TO ARMD. DURING THE REVISION, CORROSION AT INTERFACE BETWEEN DM LINER AND THE SHELL WAS NOTICED. SHELL, LINER AND HEAD WERE REVISED. THE STEM REMAINED IMPLANTED."

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 21343415 ↗
• InjuryDec 4, 2024Corroded; Corroded

  REVISION OF HIP REPLACEMENT FOR PAIN. SURGEON STATED UPON REMOVAL OF MDM LINER CORROSION WAS VISIBLE.

  Patient problems: Pain

  MAUDE report 20846998 ↗
• InjuryOct 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A RIGHT HIP REVISION DUE TO DISLOCATION BETWEEN THE ADM AND MDM LINERS. THE SURGEON WANTED TO CHANGE THE STEM AND BODY SIZE DURING REVISION HOWEVER, WAS NOT ABLE TO EXPLANT THE STEM DUE TO THE MCREYNOLDS ADAPTOR THREADS SHEARING IN THE STEM. A NEW CONE BODY WAS IMPLANTED WITHOUT THE BOLT.

  Patient problems: Joint Dislocation

  MAUDE report 20551567 ↗
• InjuryOct 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR THE 2020 REVISION. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2024, REP PROVIDED USAGE SHEETS SHOWING THAT A REVISION WAS PERFORMED FOR (B)(6) 2020 DUE TO DISLOCATION. A 28 +2.5 CERAMIC HEAD, 42E MDM METAL LINER AND 42E ADM/ MDM POLY INSERT WERE REVISED TO A 22.2 +3 METAL HEAD AND 22E 0° CONSTRAINED INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 20356212 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. PRESENTED WITH A DRAINING SURGICAL WOUND OF THE LEFT HIP. DR. OPTED TO PERFORM AN "EXTENSIVE I&D" AND SWAP OUT THE HEAD AND MDM COMPONENTS. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20218288 ↗
• InjuryJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 Dislocation

  MAUDE report 19837788 ↗
• InjuryJul 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PATIENT ORIGINALLY HAD A COMPETITOR'S RIGHT TOTAL HIP. DUE TO INSTABILITY OF THE JOINT THE CUP WAS REVISED IN MARCH OF THIS YEAR FROM COMPETITOR'S TO STRYKER. THE PATIENT THEN DISLOCATED THE HIP ON(B)(6)2024 AND HAD A CLOSED REDUCTION AT A DIFFERENT HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 19655276 ↗
• InjuryMay 9, 2024Degraded; Unstable; Degraded; Unstable

  THIS PI IS FOR ONGOING ISSUES POST- 2019 REVISION INCLUDING HIP INSTABILITY, PSEUDOTUMOR, AND INFECTION. PATIENT LEFT A VOICEMAIL REPORTING HAVING A STRYKER RIGHT RECALLED HIP. PATIENT NOTED A POLY SWAP IN 2008 DUE TO PAIN. PATIENT HAD REVISION IN 2012 DUE TO PAIN. PATIENT NOTED ALL PARTS WERE REPLACED OTHER THEN THE STEM. PATIENT HAD A REVISION IN 2016 DUE TO INFECTION WHERE ALL PRODUCT WAS REMOVED. NEW STRYKER PRODUCT IMPLANTED IN 2017 AND PATIENT HAD A CYST AND AN I&D IN 2018 THEN A REVISION IN 2019 DUE TO INFECTION. PATIENT NOTED SHE HAS CHRON'S DISEASE. UPDATE 29/JANUARY/2024 WG: AS REPORTED VIA MEDWATCH REPORTS MW5149918, MW5149919, MW5149920, MW5149921, MW5149922 (ALL REPORTS HAVE SAME EVENT DESCRIPTION BUT 1 REPORTED IMPLANT EACH): REPORTER CALLING, STATING SHE HAS HAD NUMEROUS HEALTH PROBLEMS AFTER SHE WAS IMPLANTED WITH THE "BIOLOX" HIP FROM STRYKER "SOME TIME IN 2019." REPORTER STATES SHE LEARNED THAT HER IMPLANTED HIP SYSTEM WAS "RECALLED" AND SHE HAS CONCERNS THAT HER HEALTH PROBLEMS ARE DUE TO THIS. REPORTER STATES SHE HAS MEMORY PROBLEMS, PAIN, HEADACHES, NAUSEA, AND VOMITING, HIP DISLOCATING AFTER SURGERY, AND A "CYST OR TUMOR AROUND THE HIP" CURRENTLY. REPORTER STA

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Metal Related Pathology; Unspecified Infection

  MAUDE report 19282419 ↗
• InjuryFeb 19, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION IN 2019 DUE TO INFECTION. PATIENT LEFT A VOICEMAIL REPORTING HAVING A STRYKER RIGHT RECALLED HIP. PATIENT NOTED A POLY SWAP IN 2008 DUE TO PAIN. PATIENT HAD REVISION IN 2012 DUE TO PAIN. PATIENT NOTED ALL PARTS WERE REPLACED OTHER THEN THE STEM. PATIENT HAD A REVISION IN 2016 DUE TO INFECTION WHERE ALL PRODUCT WAS REMOVED. NEW STRYKER PRODUCT IMPLANTED IN 2017 AND PATIENT HAD A CYST AND AN I&D IN 2018 THEN A REVISION IN 2019 DUE TO INFECTION. PATIENT NOTED SHE HAS CHRON'S DISEASE. UPDATE 29/JANUARY/2024 WG: AS REPORTED VIA MEDWATCH REPORTS MW5149918, MW5149919, MW5149920, MW5149921, MW5149922 (ALL REPORTS HAVE SAME EVENT DESCRIPTION BUT 1 REPORTED IMPLANT EACH): REPORTER CALLING, STATING SHE HAS HAD NUMEROUS HEALTH PROBLEMS AFTER SHE WAS IMPLANTED WITH THE "BIOLOX" HIP FROM STRYKER "SOME TIME IN 2019." REPORTER STATES SHE LEARNED THAT HER IMPLANTED HIP SYSTEM WAS "RECALLED" AND SHE HAS CONCERNS THAT HER HEALTH PROBLEMS ARE DUE TO THIS. REPORTER STATES SHE HAS MEMORY PROBLEMS, PAIN, HEADACHES, NAUSEA, AND VOMITING, HIP DISLOCATING AFTER SURGERY, AND A "CYST OR TUMOR AROUND THE HIP" CURRENTLY. REPORTER STATES SHE ADDITIONALLY HAD PROBLEMS WALKING, HAS SCAR TIS

  Patient problems: Ambulation or Postural Difficulties; Bacterial Infection; Headache; Loss of Range of Motion; Memory Loss/Impairment; Nausea; Pain; Scar Tissue; Unspecified Infection; Vomiting

  MAUDE report 18731486 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR I&D IN 2018 DUE TO INFECTION. PATIENT LEFT A VOICEMAIL REPORTING HAVING A STRYKER RIGHT RECALLED HIP. PATIENT NOTED A POLY SWAP IN 2008 DUE TO PAIN. PATIENT HAD REVISION IN 2012 DUE TO PAIN. PATIENT NOTED ALL PARTS WERE REPLACED OTHER THEN THE STEM. PATIENT HAD A REVISION IN 2016 DUE TO INFECTION WHERE ALL PRODUCT WAS REMOVED. NEW STRYKER PRODUCT IMPLANTED IN 2017 AND PATIENT HAD A CYST AND AN I&D IN 2018 THEN A REVISION IN 2019 DUE TO INFECTION. PATIENT NOTED SHE HAS CHRON'S DISEASE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18717656 ↗
• InjuryFeb 5, 2024Adverse 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 DUE TO DISCOMFORT AND WOUND DRAINAGE. AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD WERE REVISED. REP REPORTED THAT THE PATIENT HAD HAD AN INFECTION, WHICH WAS CLEARED BY (B)(6) 2024 AFTER THE REVISION. REP HAD ALSO BEEN NOTIFIED BY A COMPETITOR THAT A REVISION PREVIOUSLY TOOK PLACE (B)(6) 2023. IN THAT REVISION, A COMPETITOR POLY (TRI-POLAR) INSERT WAS IMPLANTED IN AN MDM METAL LINER WITH A BIOLOX CERAMIC HEAD. THERE WAS NO ADM/ MDM POLY INSERT IN THE PATIENT.

  Patient problems: Discomfort; Purulent Discharge

  MAUDE report 18646550 ↗
• InjuryNov 4, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REP THAT THE TOTAL HIP REPLACEMENT SURGERY WAS DONE ON (B)(6) 2023 USING TRIDENT II SHELL WITH DUO MOBILITY LINER. DURING SURGERY UPON IMPACTING THE ACTUAL METAL LINER, SURGEON WAS SURE THAT THE LOCKING MECHANISM WAS ENGAGED, VARIOUS CHECK WAS CARRIED OUT TO ENSURE METAL LINER WAS SEATED. POST OP DAY 2 THE METAL LINER WAS NOTICED TO BE DISENGAGE INFERIORLY VIA X-RAY THUS REVISION SURGERY IS REQUIRED. REVISION IS SCHEDULED ON (B)(6) 2023.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 18070555 ↗
• InjuryAug 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED AND WAS UNSUCCESSFUL. DURING THE REVISION, THE POLY INSERT WAS FOUND TO HAVE DISSOCIATED FROM THE FEMORAL HEAD AND DISLOCATED FROM THE METAL LINER. THE POLY INSERT, FEMORAL HEAD AND STEM WERE REVISED (STEM WAS REVISED TO ADD VERSION TO THE HIP CONSTRUCT). THE METAL LINER AND SHELL WERE RETAINED.

  Patient problems: Joint Dislocation

  MAUDE report 17438993 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT HIP IN (B)(6) 2019. IN (B)(6) 2019, A HEMI HIP CONSTRUCT WAS CONVERTED TO A TOTAL HIP (UNIVERSAL BIPOLAR COMPONENT HEAD REMOVED, A SLEEVE, HEAD, ADM/ MDM POLY INSERT, MDM METAL INSERT, SHELL, AND SCREWS WERE IMPLANTED. IN (B)(6) 2019, PATIENT'S LINER WAS CONVERTED TO A CONSTRAINED LINER. THE REASON FOR BOTH REVISIONS WAS NOT REPORTED TO THE REP.

  Patient problems: Insufficient Information

  MAUDE report 17296602 ↗
• InjuryMay 15, 2023Degraded; Degraded

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "PATIENT HAD A 52MM TRIDENT II CUP AND 42E MDM LINER. FEMORAL NECK OF COMPETITOR STEM NOTCHED AFTER IMPINGING ON RIM OF MDM LINER. SURGEON REVISED MDM LINER TO A 0 DEGREE CONSTRAINED LINER." UPDATE 08-MAY-2023 MF: PER MEDICAL REVIEW, "THIS X-RAY SHOWS A TROCHANTERIC CABLE PLATE WITH MULTIPLE CIRCLAGE WIRES, SOME OF WHICH HAVE BROKEN AND ARE FRAYED WITH SOME METALLIC DEBRIS." THE REVIEWING CLINICIAN FURTHER STATED THAT "AT LEAST FIVE CABLES ARE PRESENT WITH AT LEAST ONE OF THE CABLES AND POSSIBLY TWO THAT HAVE BROKEN." IT WAS NOT REPORTED HOW THESE FRACTURED CABLES WERE ADDRESSED DURING THE REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 16930190 ↗
• InjuryMay 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "REVISION TODAY WAS SECONDARY TO DISLOCATION. THE CERAMIC 28MM HEAD WAS INSIDE THE PLASTIC LINER AND BOTH DISLOCATED AS A UNIT FROM THE METAL INSERT. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Joint Dislocation

  MAUDE report 16843387 ↗
• InjuryDec 22, 2022Material Erosion; Material Erosion

  AS REPORTED: "PERFORMED A LEFT HIP REVISION DUE TO ALTR. HE EXPLANTED THE INSERT, LINER AND BIOLOX HEAD. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE TRUNNION (I.E. WEAR, ETC).

  Patient problems: Metal Related Pathology

  MAUDE report 16040160 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER CLINICAL POST MARKET FOLLOW-UP: THERE WAS NO EXPLANATION PROVIDED. THE PATIENT SELECTED 'NO' FOR SATISFACTION. A FOLLOW-UP QUESTIONNAIRE WAS COMPLETED BY THE SUBJECT WHERE THEY ANSWERED "NO" FOR SATISFACTION WITH THE RESULTS OF THE STUDY HIP REPLACEMENT. NO ADDITIONAL DETAILS CAN BE PROVIDED AS THIS WAS A PHONE VISIT AND NO CLINICAL NOTES WERE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 15803376 ↗
• InjurySep 7, 2022Corroded; Corroded

  METAL MDM LINER DEVELOPED BLACK FILM DUE TO METALLOSIS AT LINER/CUP INTERFACE. A CULTURE WAS TAKEN PREOPERATIVELY INDICATING INFECTION. PATIENT DEVELOPED METALLOSIS FROM COCR LINER. POSTERIOR PSEUDO CAPSULE REMOVED DUE TO METAL MATERIALS. UNSURE WHETHER PATIENT WILL HAVE ANY LONG-TERM EFFECTS. ALSO, OSTEOLYSIS DEVELOPED AROUND THE CUP, AS WELL AS A LARGE CYST IN THE POSTERIOR SUPERIOR ASPECT OF ACETABULUM. A (NON-STRYKER) BIOLOGIC WAS INJECTED INTO THE CYST, WHICH EJECTED OUT OF THE POSTERIOR OF THE ACETABULUM AND INTO THE BLADDER. UNCLEAR WHETHER THAT WAS THE RESULT OF OSTEOLYSIS FROM THE LINER OR IMPROPER APPLICATION BY THE SURGEON OF THE BIOLOGIC.

  Patient problems: Foreign Body Reaction; Osteolysis; Unspecified Infection

  MAUDE report 15369546 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DETERMINED TO HAVE A PSEUDO CAPSULE POSSIBLY ATTRIBUTED TO ELEVATED COBALT LEVELS. MDM LINER WAS EXPLANT AND A BLACK SUBSTANCE WAS NOTED ON THE BACKSIDE.

  Patient problems: Cancer; Foreign Body Reaction

  MAUDE report 15367704 ↗
• InjurySep 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "PT. PRESENTED "FOLLOWING MULTIPLE DISLOCATIONS". DR. OPTED TO SWAP OUT 3 COMPONENTS, MAKING SOME CHANGES TO STEM ANTEVERSION/POSITION. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES."

  Patient problems: Joint Dislocation

  MAUDE report 15341168 ↗
• 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 14135738 ↗