ARTICUL/EZE 1365-21-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 10603295033172), received between Jul 12, 2017 and Sep 14, 2026 — classified as 277 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (139 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 7, 2021Class IITerminated

   Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

   Z-1845-2021 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to instability.Affected side: Right Hip.

  Patient problems: Joint Laxity

  MAUDE report 50754614 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50543212 ↗
• InjuryAug 6, 2026Degraded

  Patient problems: Joint Laxity

  MAUDE report 50168166 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was premature replacement head and polyethylene.

  Patient problems: Insufficient Information

  MAUDE report 50056014 ↗
• InjuryJul 28, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised due to dislocation.Affected side: Left Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50054694 ↗
• InjuryJul 27, 2026Device Dislodged or Dislocated

  It was reported that patient head came out of the constrained liner. Dr. replaced the constrained liner and added a longer head for stability. There was no mention of issues with the implants. The surgeon thought the head levered out due to not having a long enough offset.DOI- (b)(6) 2025.DOR-(b)(6) 2026.Affected side-Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50045507 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON PERFORMED A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25534826 ↗
• InjuryMay 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR SWITCHED HEAD AND LINER TO GAIN STABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25110658 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 24861409 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NOT STABLE-HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24590464 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: (B)(6) 2025.

  Patient problems: Joint Dislocation

  MAUDE report 24006520 ↗
• InjuryDec 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 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 FOR DISLOCATION. THE NON-ARTICULAR SURFACE OF THE REVISED POLYETHYLENE ACETABULAR LINER SHOWS MINOR YELLOWING.

  Patient problems: Joint Dislocation

  MAUDE report 23924589 ↗
• InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23905895 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD TRAUMATIC FALL AND DISLOCATED MULTIPLE TIMES. DOCTORS WENT TO DM. NO ADDITION INFORMATION IS AVAILABLE. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23463907 ↗
• InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF J&J CORAIL STEM AND PINNACLE CUP FOR DISLOCATION. IT WAS REPORTED THAT THE ISSUE WAS WITH THE POSITIONING OF THE CUP AND STEM FROM THE PRIMARY PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 23427054 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DONE IN 1998 WHICH WAS REVISED IN 2015. PATIENT HAS AN INFECTION AND IS NOT VERY HEALTHY. DOCTOR CHOSE TO REMOVAL ALL PARTS THAT HE COULD EASILY REMOVE AND WASH OUT AS BEST HE COULD AND ABLE TO REMOVE THE PROXIMAL BODY AND HEAD EASILY. THE DISTAL STEM (240MM) WAS WELL FIXED AND EVEN AFTER HOOKING UP THE STEM INSERTER AND SLAP HAMMER SHOWED NO SIGNS OF LOOSENING. THE CUP WAS A COMPETITOR PRODUCT. AFTER IRRIGATING AND DEBRIDEMENT PUT THE SAY SIZE IMPLANTS BACK IN AND THEN REDUCED THE HIP. ACTIVITY LEVEL - YES. DOI: 1998. DOR: 2015. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22891473 ↗
• InjuryJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF CONSTRAINED LINER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22642060 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SURGEON HAD A PATIENT PRESENTED WITH A DISASSOCIATED PINNACLE ALTRX LINER REQUIRING REVISION. THERE WAS LOOSENING OF 48X32 N ALTRX LINER AT NON CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. THE FEMORAL HEAD WAS DISPLACED SUPERIOR AND RUBBING THE SUPERIOR RIM OF THE CUP. AFTER EXPLANTING THE FEMORAL HEAD AND REMAINING LINER, THOROUGH WASHOUT/DEBRIDEMENT, AND CUP/STEM STABILITY/FIXATION CHECKED, A DM CONSTRUCT WAS DETERMINED TO BEST CORRECT POSSIBLE CAUSATIONS. HIP WAS REDUCED WITH A 48X41 DM LINER, 41X22.225 HEAD LINER, AND 22.225 METAL HEAD. STABILITY WAS SATISFACTORY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22495989 ↗
• InjuryJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD CHRONICALLY DISLOCATED FROM ORIGINAL SURGERY DONE IN 2020. SURGEON PLANS TO USE A CONSTRAINED LINER. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. AFFECTED AREA: UNK HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22160631 ↗
• InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH 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 RECURRENT DISLOCATIONS POST FALL. AT REMOVAL THE ACETABULAR LINER SHOWED MODERATE YELLOWING.

  Patient problems: Joint Dislocation

  MAUDE report 21979287 ↗
• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A HIP DONE IN 2016 AND HAD BEEN DOING WELL UNTIL A COUPLE MONTHS AGO. PATIENT HAS A LARGE LUMBER FUSION. PATIENT HAS DISLOCATED A COUPLE TIMES OVER THE PAST COUPLE MONTHS. THE DOCTOR DECIDED TO CHANGE THE LINER TO A CONSTRAINED LINER AND INCREASED NECK LENGTH FROM +1 TO +5. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21873191 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN. SURGEON PERFORMED POLY AND HEAD SWAP. THERE WAS NO LOOSENING AND NO INFECTION. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 21855736 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF A C-STEM PINNACLE. THE REASON FOR REVISION WAS BECAUSE THE STEM WAS LOOSE, AND THE HIP WAS UNSTABLE. NO ALLEGATION WAS MADE BY THE SURGEON IN RELATION TO THE LOOSE STEM. THE CEMENT/STEM INTERFACE WAS LOOSE. CEMENT BONE/BONE INTERFACE WAS SOUND. THE SURGEON NOTED THAT IT WAS A VERY DIFFICULT PRIMARY. IT WAS DONE BY A DIFFERENT SURGEON AND THEY STRUGGLED TO GET A SZ 1HO C-STEM IN. THE X-RAY SHOWED THAT DUE TO THE ANTERIOR-LATERAL APPROACH, THE STEM WAS PUT IN VARUS. THE HIP WAS UNSTABLE BECAUSE AT THE PRIMARY SURGERY, THE CUP WAS PLACED AT THE WRONG VERSION. THE CUP WAS EXPLANTED. IT WAS EXTREMELY WELL FIXED. THE LINER WAS EXPLANTED WITH THE SHELL, BUT THE LOT NUMBER IS UNREADABLE AS THE LINER WAS DAMAGED WHEN EXPLANTED. RECLAIM BIMENTUM WAS IMPLANTED. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 21687926 ↗
• InjuryMar 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21652714 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2016 PATIENT UNDERWENT REVISION FOR DISLOCATION. AT SOME POINT, PATIENT WAS DISLOCATED AGAIN. REVISION TOOK PLACE (B)(6) 2025 WITHOUT INCIDENT A32+1 AND +4 NEUTRAL 32X52 CONSTRAINED LINER WAS USED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21634654 ↗