ARTICUL/EZE 1365-30-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295033356), received between Nov 21, 2017 and Sep 8, 2026 — classified as 31 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported that patient had implanted non-Synthes cup with constrained liner, Depuy stem and head. Patient dislocated after a hard fall. Surgeon removed head and liner and implanted same size non-Synthes liner and Depuy head.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Right Hip.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 50673169 ↗
• InjuryJun 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22331941 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, WASHED IT OUT, REMOVED DUAL MOBILITY LINER AND SHELL. RE-IMPLANTED SAME IMPLANTS AND CLOSED THE PATIENT UP. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20189194 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19938659 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FEMORAL HEAD BALL CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818785 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE EXACT ALLEGATION AGAINST THE CUP AND STEM? THE HEAD DISSOCIATED FROM THE POLY LINER.

  Patient problems: Insufficient Information

  MAUDE report 18791313 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A FRACTURE AT GREATER TROCH, POSSIBLE INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18444035 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 15 DEC 2023 PERTAINING TO NON MOM CONSTRUCT WAS REVIEWED BY CLINICIAN. (B)(6) 2023 MRI DEMONSTRATES RIGHT HIP ARTHROPLASTY, MILD INCREASED SIGNAL ON FLUID SENSITIVE SEQUENCES ALONG THE FEMORAL STEM. MODERATE RIGHT GREATER TROCHANTERIC BURSITIS VERSUS HEMATOMA/SEROMA. THE PATIENT ALSO REPORTED HAVING WEAKNESS AND PAIN. THE IMPRESSION IS MILD TROCHANTERIC BURSITIS. ILIOPSOAS TENDINITIS APPEARS TO BE FROM PROMINENCE OF THE IRRITATING PSOAS TENDON ITSELF. CORTICOSTEROID INJECTION IS RECOMMENDED. DOI: (B)(6) 2022 ( STEM). DOI: (B)(6) 2023 (LINER, HEAD). DOE: (B)(6) 2023. RIGHT HIP.

  Patient problems: Fatigue; Hematoma; Inflammation; Muscle/Tendon Damage; Pain; Seroma; Swelling/ Edema

  MAUDE report 18442486 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE EVENT: ELEVATED CHROMIUM LEVEL AFTER FIRST REVISION. DOI: (B)(6) 2007 STEM. DOI: (B)(6) 2022 HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 17835950 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17603155 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REASON FOR REVISION WAS SURGEON SUSPICION OF INFECTION. IT IS UNKNOWN IN INFECTION WAS PRESENT OR NOT. THE PINNACLE DUAL MOBILITY METAL LINER, POLY LINER AND METAL HEAD WERE REMOVED BEFORE I&D. NEW IMPLANTS OF THE SAME SIZES WERE THEN IMPLANTED. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17208124 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN . DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP.

  Patient problems: Pain

  MAUDE report 17191471 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FEMORAL HEAD WAS REVISED DUE TO POSSIBLE INFECTION. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16731387 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SEEMS TO BE INFECTED. WASHED OUT HIP AND REPLACED DUAL MOBILITY HEAD WITH SAME SIZE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16140600 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022.. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14653565 ↗
• InjuryMay 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION/ INSTABILITY. HEAD WAS EXCHANGED. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 14468851 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13928069 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO JOINT INSTABILITY. THE MDM CONSTRUCT WAS REVISED WITH PINNACLE CONSTRAINED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13366352 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOOSENING WAS FROM INFECTION. THIS WAS CONSIDERED TO BE STAGE TWO REVISION. PROSTALIC WAS IMPLANTED FOR CONTINUUM CARE. THE CASE IN JUNE WAS AN IRRIGATION AND DEBRIDEMENT AND CONVERTED TO A DUAL MOBILITY. SURGERY TIME WAS EXTENDED TO REMOVE THE IMPLANTS AND ALSO TO IRRIGATE AND DEBRIDE THE TISSUES AND ALLOWING FOR MOLD TO CURE.

  Patient problems: Unspecified Infection

  MAUDE report 13051068 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED AN INFECTION FOR THE SECOND TIME. THE LINER AND HEAD WAS REMOVED AND REPLACED. THE PATIENT WAS I&D AND CULTURES WERE DONE. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12094710 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT FOR INTERCOCCUS FECALUS. LINER, HEAD, POLY AND ELIMINATOR WERE EXCHANGED AFTER IRRIGATION AND DEBRIDEMENT. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12088772 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A CONSTRAINED LINER AND HEAD FOR STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN , DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11876767 ↗
• InjuryApr 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DIR 68772 RECEIVED FROM TGA IN RELATION TO DEPUY - PINNACLE HIP REPLACEMENT. DATE OF IMPLANT: (B)(6) 2011, DATE OF EXPLANT: (B)(6) 2020, CLINICAL EVENT INFORMATION: PARTNER HAD A HIP REPLACEMENT IN 2011. LAST SURGERY REPLACED THE METAL HIP JOINT AND 4 LARGE SCREWS.(B)(6) 2011 HIP DISLOCATED AGAIN AFTER NO INCIDENT. WAS THE WORST PAIN EVER. HAD AN APPOINTMENT WITH SURGEON (B)(6) 2011. THEY CAN DO NOTHING FOR HIM. HE IS LEFT WITH A PERMANENT DISABILITY. FIVE MONTHS AFTER SURGERY HAS TO WALK WITH A CRUTCH.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11633509 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10219331 ↗
• InjuryMay 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HIP DISLOCATED. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10044598 ↗