ARTICUL/EZE 1365-15-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295033134), received between Jan 25, 2018 and Jun 3, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K843909, K883460); 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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25375677 ↗
• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DISLOCATED FROM CONSTRAINED INSERT. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21712422 ↗
• InjuryDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS DONE IN A DIFFERENT HOSPITAL. THE PATIENT DISLOCATED SEVERAL TIMES. A CONSTRAINED LINER WAS IMPLANTED IN 2022. SHE DISLOCATED AGAIN ON (B)(6) 2024. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20821644 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON WANTED TO WASH OUT THE PATIENT AND EXCHANGE THE HEAD & LINER. DOI: UNKNOWN DOR: (B)(6), 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18861282 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: AS PER REVIEW " ON (B)(6) 2024, THE PATIENT HAS PAIN, AND SHE FEELS THE LEFT HIP IS "PUFFY." THE PATIENT IS POSITIVE FOR BACILLUS NON ANTHRACIS AND METAL LEVELS OF BOTH CO/CR REMAIN ABOVE 10. THERE IS PLAN FOR A REVISION SECONDARY TO INFECTION WITH PLACEMENT OF AN ANTIBIOTIC SPACER. ALSO THE ENTIRE CONSTRUCT IS PLANNED TO BE REMOVED IN ORDER TO ALSO REMOVE "THE METAL GENERATOR IN HER HIP POSSIBLY FROM DAMAGED TRUNNION." THERE ARE NO REVISION NOTES PROVIDED AT THIS TIME. THERE IS X-RAY NOTATION OF A HEALED DISTAL FEMORAL FRACTURE THOUGH PATIENT HAS A HISTORY OF A MOTOR VEHICLE ACCIDENT THAT CAUSED THIS PRIOR TO THE ORIGINAL L THA.

  Patient problems: Erythema; Fall; Fatigue; Fluid Discharge; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 17623779 ↗
• InjuryJan 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE OF THE PATIENTS TOTAL HIP IS UNKNOWN. PATIENT HAD THEIR HIP REVISED AT THE (B)(6) CLINIC ON (B)(6) 2018. SALES REP IS NOT AWARE OF WHO THE SURGEON WAS FOR THAT REVISION, AND AS TO WHY THE HIP WAS REVISED. PATIENT HAS A DEPUY STEM WITH A 28MM +15.5 FEMORAL HEAD IMPLANTED. THE ACETABULAR COMPONENT IS A CEMENTED COMPETITOR CONSTRAINED LINER. THE CEMENTED LINER HAS BECOME DISENGAGED FROM THE ACETABULUM, CAUSING THE PATIENTS HIP TO DISLOCATE. SURGEON IS PLANNING TO REVISE THE CEMENTED LINER, AND EXCHANGE THE FEMORAL HEAD. THE CURRENT FEMORAL STEM IS GOING TO REMAIN IMPLANTED. REP IS UNABLE TO RETRIEVE ANY PART NUMBERS FOR THE FEMORAL STEM COMPONENT. A NEW COMPETITOR CEMENTED CONSTRAINED LINER WAS CEMENTED INTO PLACE AND A 36MM +15.5 DEPUY FEMORAL HEAD WAS OPENED AND IMPLANTED. THE HIP WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. LOOSENING OF THE COMPETITOR LINER WAS REPORTED AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16102974 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15699712 ↗
• InjuryMay 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION - RECURRENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS PROBABLY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2022. DATE OF REVISION: NOT SPECIFIED (LEFT HIP) TREATMENT: REVISION OF DEPUY HEAD AND COMPETITOR LINER.

  Patient problems: Joint Dislocation

  MAUDE report 14518264 ↗
• InjuryMay 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OFFICE NOTES (B)(6) 21 INDICATE THE PATIENT HAS BEEN EXPERIENCING PAIN, INSTABILITY, SUBLUXATIONS AND PREVIOUS POSTERIOR DISLOCATION. IT WAS NOTED THAT FOR THE (B)(6) 2021 DISLOCATION THE PATIENT HAD A CLOSED MANIPULATION / REDUCTION IN THE ER AND WAS THEN BRACED. NO ADDITIONAL INTERVENTION AT THIS TIME, SURGEON INDICATES THE PLAN IS TO TREAT CONSERVATIVELY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Pain

  MAUDE report 11831209 ↗
• InjuryJul 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RIGHT HIP REV - ORIGINAL DONE (B)(6) 2001. PATIENT HAD SOME INSTABILITY AND DISLOCATIONS. REMOVED PLY AND HEAD. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, FACILITY NAME OF ORIGINAL IMPLANT --> MILLARD FILLMORE GATES, WAS DEVICE EXPLANTED? --> TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: --> DISLOCATION, DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, IF YES, DATE OF REVISION SURGERY. --> (B)(6) 2020, REASON FOR REVISION SURGERY. --> DISLOCATION, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFO

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10291647 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI; UNKNOWN. DOR: (B)(6) 2020. LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10097566 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D FOR INFECTION AND HEAD AND BIPOLAR SHELL WERE EXCHANGED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9569680 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. POLY WEAR. HEAD/LINER EXCHANGE. DEPUY REPLICA STEM WELL FIXED. DOI: (B)(6) 1999; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8836278 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL HIP ARTHROPLASTY STATUS POST REVISION TOTAL HIP ARTHROPLASTY AFTER FAILED METAL ON METAL HIP REPLACEMENT DONE ELSEWHERE. REVISION NOTES STATED THAT A SUBSTANTIAL BONE LOSS WAS NOTED CAUSED BY INFECTION. ALL OTHER IMPLANTS WERE COMPETITORS. ON (B)(6) 2013 - (B)(6) 2013, (LEFT HIP) 4TH REVISION.

  Patient problems: Injury; No Code Available; Unspecified Infection

  MAUDE report 8821285 ↗
• InjuryJun 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFFECTED SIDE IS RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8692584 ↗
• InjuryMar 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: NOT REPORTED, (RIGHT HIP).

  Patient problems: Joint Dislocation; Test Result

  MAUDE report 8424550 ↗
• InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH OPEN REDUCTION AFTER 1ST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8178500 ↗
• InjurySep 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS A METAL REACTION OCCURRING DUE TO ELEVATED METAL IONS, SEROMA AND PAIN THAT THE PATIENT HAS BEEN EXPERIENCING FOR THE PAST FEW YEARS. DOI: (B)(6) 2008; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Not Applicable; Pain; Seroma; Test Result

  MAUDE report 7868689 ↗
• InjuryJun 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO INDICATED THAT THE IMPLANT DATE OF THE CUP IS UNKNOWN. CONSTRAINED LINER AND FEMORAL HEAD WERE IMPLANTED ON (B)(6) 2018. DOI: (B)(6) 2018; DOR (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7600295 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATED THAT LEFT TOTAL HIP REVISED FOR FAILED STRYKER ACETABULAR CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7372868 ↗
• InjuryJan 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. (B)(6) 2017; (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7218078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K843909, K883460. One submission often covers many models, so check the product and lot details in each record.

• Z-1845-2021 · May 7, 2021 · Terminated
  DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR