ARTICUL/EZE 1365-24-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10603295033202), received between Aug 25, 2017 and Sep 21, 2026 — classified as 64 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (45 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50847994 ↗
• InjuryJan 6, 2026Osseointegration Problem

  IT WAS REPORTED THAT GLENOID IMPLANT WAS FAILED, SPECIFICALLY ASEPTIC LOOSENING AT THE BONE-TO-IMPLANT INTERFACE, WHICH LED TO A REVISION PROCEDURE. IT WAS CONVERTED TO REVERSE. DOI: (B)(6) 2024. DOR: (B)(6) 025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23976447 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD DEVICE BROKE WHILE IN USE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED, HOWEVER IT WAS UNKNOWN IF ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510861 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22366465 ↗
• InjuryMay 7, 2025Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  "THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO DISLOCATION AND INSTABILITY. AT REVISION THE FEMORAL HEAD HAD CORROSION. THE ACETABULAR LINER SHOWED NECK IMPINGEMENT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21981517 ↗
• InjuryFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21448242 ↗
• InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP HAD TO BE REVISED A SECOND TIME, WITHIN A TWENTY-FOUR HOUR PERIOD, BECAUSE IT HAD BECOME DISLOCATED. THE PATIENT'S HIP HAD BEEN INITIALLY REVISED THE PRIOR EVENING DUE TO INFECTION. DURING THAT SURGICAL PROCEDURE, THE PATIENT'S PRIMARY HIP IMPLANTS WERE REMOVED AND REPLACED BY PROSTALAC COMPONENTS (ANTIBIOTIC COATED STEM, POLYETHYLENE CUP, AND A METAL FEMORAL HEAD). UPON EXAMINATION OF THE PATIENT'S HIP DURING THE SECOND OPEN REVISION PROCEDURE, IT WAS DETERMINED THAT THE PROSTALAC STEM HAD ROTATED WITHIN THE PATIENT'S FEMUR, LIKELY CAUSED THE DISLOCATION. THE ROTATION OF THE STEM WAS DUE TO LOOSENESS, CAUSED BY AN UNRECOGNIZED FEMUR FRACTURE THAT LIKELY OCCURRED DURING THE INITIAL REVISION PROCEDURE. THE FRACTURE WAS REDUCED BY THE USE OF CABLES AND THE STEM WAS THEN FURTHER STABILIZED BY THE APPLICATION OF BONE CEMENT. A SHORTER FEMORAL HEAD, IN COMPARISON TO THE HEAD USED THE EVENING BEFORE. WAS APPLIED. THE HIP WAS THEN REDUCED AND PUT THROUGH A RANGE OF MOTION TO CHECK (VERIFY) ITS STABILITY. AFFECTED SIDE: RIGHT HIP. THIS REPORT CAPTURES PATIENT'S SECOND REVISION WHILE RELATED COMPLAINT (B)(4) CAPTURES THE 1ST REVISION DUE TO INFEC

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21162033 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION. CUP AND HEAD WERE EXPLANTED AND NEW CUP AND HEAD (WITH MODIFIED VERSION) WERE IMPLANTED. THERE WAS NO LOSS OF TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20384758 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. THERE WERE NO BROKEN INSTRUMENTS OR IMPLANTS. THERE WAS NO INFECTION. THERE WERE NO DELAYS IN THE CASE. NO OTHER INFORMATION WAS KNOWN. THE LOT CODE ON IMPLANTS COULD NOT BE SEEN AS IT HAD WORN AWAY OR THE LINER HAD BROKEN DURING EXTRACTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19741445 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON WASHED OUT THE IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19471752 ↗
• InjuryJan 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ACETABULAR LINER AND HEAD BALL WERE REPLACED DUE TO DISLOCATION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2019, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18565465 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A, WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO B. IT WAS STATED THAT THE CORAIL PINNACLE METALOSE IN THE EVENT DESCRIPTION. YES, ULTAMET. C. PLEASE CLARIFY IF THERE WAS IMPLANT LOOSENING ELEVATED METAL IONS OR FOREIGN BODY REACTION, ETC. PLEASE KINDLY PROVIDE DETAILS. YES.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 18181808 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEAD AND LINER EXCHANGE DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18091624 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH SOME DISCOMFORT IN HER HIP. IT WAS OBSERVED ON X-RAY THAT THERE WAS SOME ECCENTRIC WEAR OF THE ACETABULAR LINER. PATIENT HAD A LINER AND HEAD EXCHANGE. LINER WAS EXAMINED TO HAVE MINIMAL WEAR. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2017. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Discomfort

  MAUDE report 17894867 ↗
• InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17571542 ↗
• InjuryJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17319904 ↗
• InjuryDec 21, 2022Device 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 PINNACLE LINER AND HEAD. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/ WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFLAMMATION AND DISCOMFORT. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: PRE OP XRAYS. IS THE PATIENT PART OF A CLINICAL STUDY: NO. (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 INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: Discomfort; Inflammation; Joint Dislocation

  MAUDE report 16022789 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. DOCTOR DID A WASHOUT WITH HEAD AND LINER EXCHANGE. ZIMMER CUP AND LINER. DEPUY STEM AND HEAD. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15542389 ↗
• InjurySep 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE HIP PAIN AND DYSFUNCTION, LARGE FRAGMENTS OF POLY (DETERMINED AS "PETALS" OF LOCKING BORE OF CONSTRAINED LINER) AND METALLOSIS PRESENT, LOCKING RING LOOSE/DISENGAGED, DISLOCATION WITHOUT DIFFICULTY. ORIGINAL STEM AND CUP FROM 2014 REVISION STABLE AND LEFT IN-SITU. SURGEON AWARE THAT SKIRTED HEAD SHOULD NOT BE USED WITH CONSTRAINED LINER AND WAS CAUSE OF FAILURE. PREVIOUS REVISION COMPLETED DUE TO INSTABILITY/DISLOCATION.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 15336783 ↗
• InjuryMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2019 WHERE A CORAIL PINNACLE WAS IMPLANTED. AS PER THE NOTES, THE PATIENT DISLOCATED 2 TIMES AND WAS THEN BROUGHT BACK TO THEATRE ON (B)(6) 2019 WHERE THE PINNACLE LINER WAS EXCHANGED TO A CONSTRAINED LINER AND A LONGER FEMORAL HEAD IMPLANTED. PATIENT HAS NOW PRESENTED WITH PAIN WITH A THE X RAY SHOWING THE HIP TO BE DISLOCATED. ACCORDING TO THE PATIENT, HIS HIP HAS NEVER BEEN RIGHT AND HE HAS SUFFERED WITH PAIN SINCE THE ORIGINAL INDEX SURGERY. THE X RAY IMAGES SHOW A DISLOCATED HIP, LOCKING RING AROUND THE NECK AND THE RING THAT LOCKS THE POLY INTO THE SHELL, BROKEN AND LYING IN THE SURROUNDING SOFT TISSUE. ON OPENING THE HIP, BACKEND SOFT TISSUE WAS EVIDENT, THE POLY LOCKING RING WAS LOCATED, BENT AND BROKEN AND THE POLY LINER WAS FOUND EXERTED IN THE SOFT TISSUE AND NOT IN THE SHELL. THE BLACKENED TISSUE WAS REMOVED, THE LINER REMOVED. A NEW CONSTRAINED LINER WAS IMPLANTED AND A HEAD WITHOUT A ¿SKIRT¿ IMPLANTED (THE PREVIOUS HEAD AD A SKIRT AND WOULD HAVE RESULTED IN MORE IMPINGEMENT) ONLY THE PRODUCTS REMOVED IN THIS SURGERY HAVE BEEN LISTED. DOI: (B)(6) 2019. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Pain

  MAUDE report 14461181 ↗
• MalfunctionApr 1, 2022Difficult to Insert; Difficult to Insert

  PROSTALAC CUP X2 WOULD NOT FIT 32MM HEAD IN. HIP WOULD NOT REDUCE. ATTEMPTED TWO DIFFERENT CUPS, BOTH SAME LOT NUMBER, BOTH SAME ISSUE. EVEN AFTER CUP WAS TAKEN OUT, HEAD WOULD NOT PHYSICALLY FIT IN THE CUP, AS IF THE CUP WAS TOO SMALL. SURGICAL DELAY OF ONE HOUR OCCURRED. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978340 ↗
• InjuryMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT NO RECORDS PREVIOUS WERE AVAILABLE ON PATIENT¿S PREVIOUS SURGERY BUT SURGEON BELIEVES IT WAS APPROXIMATELY 2010. PATIENT REPORTS DISLOCATED HIP IN SEPARATE CITY THE PREVIOUS WEEKEND. THIS COMPLAINT WAS CREATED TO CAPTURE THE DISLOCATION THAT WAS MENTIONED IN THE EVENT DESCRIPTION UNDER (B)(4). DOI: UNKNOWN; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13900530 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ACUTE INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12777902 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT HAD CHRONIC PAIN, DISCOMFORT, ABDOMINAL DISTENTION, MUSCLE WEAKNESS, DIFFICULTY WALKING, URINARY RETENTION AND LIMITED RANGE OF MOTION POST REVISION. DOI: (B)(6) 2017. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Abdominal Distention; Ambulation or Postural Difficulties; Discomfort; Fatigue; Loss of Range of Motion; Pain; Urinary Retention

  MAUDE report 12758973 ↗
• InjuryOct 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  QUESTIONS: WITH REGARDS TO THIS, PLEASE CONFIRM IF ANY OF THE FOLLOWING INFORMATION IS AVAILABLE: A. PATIENT'S NAME: B. PLEASE CONFIRM IF THERE WAS ANY DEPUY PRODUCT INVOLVED IN PREVIOUS REVISIONS DUE TO DISLOCATION? IF YES, PLEASE PROVIDE PRODUCT AND LOT DETAILS. OR IF THIS WAS PREVIOUSLY REPORTED, PLEASE PROVIDE THE COMPLAINT NUMBER? ANSWERS: A. PATIENT NAME: (B)(6). B. ORIGINAL IMPLANTS: ALTRX NEUTRAL LINER 50X32 MM (REF (B)(4) ,LOT J86W18) AND ARTICUL/EZE 32 +1 HEAD (REF (B)(4), LOT D20110192). THE PRODUCTS EXPLANTED IN THE MDR WERE FROM HER FIRST REVISION, SWAPPING THE NEUTRAL LINER TO THE +410° AND A +13 HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 12569751 ↗