ARTICUL/EZE 1365-29-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295033349), received between Aug 21, 2018 and Sep 3, 2026 — classified as 47 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50595682 ↗
• InjuryApr 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD LINER EXCHANGE BECAUSE PATIENT DISLOCATED A COMPETITOR'S LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25019436 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. DOCTOR DID WASH OUT AND SWAPPED HEADS. THERE WAS NO DELAY AND NO PROBLEM WITH IMPLANTS. THERE WAS NO ADDITIONAL INFORMATION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24498387 ↗
• InjuryMar 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED. HEAD WAS SWAPPED FOR A 22.225+7. THERE WAS NO PATIENT INJURY OR DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24496634 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON WASHED OUT DIS POLY LINER SWAP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23888043 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTED HIP 2 + YEARS POST THA. ALL WELL-FIXED COMPONENTS WERE REMOVED AND A PROSTALAC WAS PLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23584390 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT (B)(4) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(4) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ACETABULAR CUP, PINNACLE DM LINER, BI-MENTUM POLY LINER AND FEMORAL HEAD WERE REVISED FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22667119 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO PATIENT'S LEG LENGTH DISCREPANCY. SURGEON REVISED AND PUT IN A SHORTER CONSTRUCT. NO LOTS ABLE TO BE RETRIEVED FROM EACH IMPLANT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 22535069 ↗
• InjuryJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A KNEE AND HIP REPLACEMENT. THE HIP MALFUNCTIONED 2 YEARS LATER AND THE HIP WAS REPLACED, BUT IT AGAIN DISLOCATED. PATIENT DOES NOT HAVE THE ITEMS OR SERIAL NUMBERS.

  Patient problems: Joint Dislocation

  MAUDE report 22346330 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION. PRIOR TO REVISION, IMAGING AND MRI REVEALED FLUID SURROUNDING THE DEPUY COMPONENTS AND AN INFLAMMATORY RESPONSE IN THE JOINT. THE PATIENT HAD SUFFERED PHYSICAL INJURY, EMOTIONAL, DISTRESS, MEDICAL EXPENSES, LOSS OF ENJOYMENT OF LIFE, AND PERMANENT IMPAIRMENT. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP

  Patient problems: Colitis; Cyst(s); Distress; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; Pain; Skin Inflammation/ Irritation; Swelling/ Edema; Synovitis

  MAUDE report 22330693 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS HAVING TROUBLE WITH STABILITY/DISLOCATIONS DESPITE CORRECTLY POSITIONED IMPLANTS. SURGEON REMOVED DUAL MOBILITY CONSTRUCT AND PUT A CONSTRAINED CONSTRUCT IN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22292566 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN HAS OCCURRED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. AFFECTED AREA: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22029352 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED EXPLANTED / DUE TO INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21656574 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21172400 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 20522215 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH DRAINAGE POST THA AFTER BEING DIAGNOSED WITH UNCONTROLLED DIABETES. PATIENT ALSO HAS CIRRHOSIS OF THE LIVER. AN I&D WITH MODULAR COMPONENT EXCHANGE WAS PERFORMED WITHOUT DELAY NOR PATIENT HARM. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20400331 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THESE IMPLANTS DUE TO INFECTION, THEN THE SURGEON REPLACED THEM WITH NEW ONES. THE CUP AND SCREWS FROM THE PRIMARY SURGERY WERE LEFT IMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20371136 ↗
• InjuryMay 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 19437051 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED. DR WASHED IT OUT AND REPLACED THE LINERS AND HEAD. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024, DOR- (B)(6) 2024, AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19280412 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION AND NEW IMPLANTS WERE IMPLANTED. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18987837 ↗
• InjurySep 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EARLY STAGE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023 AND DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17805296 ↗
• InjuryAug 21, 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: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17584798 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASHOUT WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 17479395 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17389395 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND SEROMA. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Seroma

  MAUDE report 17267116 ↗