NA 1365-52-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 683 adverse event reports that list this exact device (DI 10603295033936), received between Jan 7, 2013 and Sep 18, 2026 — classified as 667 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (163 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 683 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  It was reported that patient was revised due to femoral stem was loose and the corail stem was loose and at the bone to implant interface.DOI (B)(6) 2023.DOR (B)(6) 2026.Affected side-Right.

  Patient problems: Joint Dislocation

  MAUDE report 50823299 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that metal liner and metal head were replaced due to the patient having high levels of metal ions in blood. They were replaced with a poly liner and TS ceramic head. No delay in case.DOI: (b)(6), 2007DOR: (b)(6), 2026Affected side: Left Hip

  Patient problems: Metal Related Pathology

  MAUDE report 50714221 ↗
• InjuryJul 27, 2026Device Dislodged or Dislocated

  It was reported that a revision THA was performed due to dislocation.DOI-(b)(6) 2026.DOR-(b)(6) 2026.Affected side-Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50022290 ↗
• InjuryJun 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED AS PATIENT DISLOCATED. 36+5 METAL HEAD AND 36 X 54 +4 10 LINER WERE REVISED. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25613402 ↗
• InjuryJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A METAL-ON-METAL PINNACLE CUP WITH NOTICEABLE METAL DEBRIS PRESENT WITHIN THE HIP JOINT. THE TRUNNION WAS INSPECTED AND FOUND TO BE IN GOOD CONDITION WITHOUT SIGNIFICANT DAMAGE OR CORROSION. THE DOCTOR ELECTED TO RETAIN THE EXISTING CUP AND REVISE THE CONSTRUCT BY IMPLANTING A POLYETHYLENE LINER AND FEMORAL HEAD. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 25518979 ↗
• InjuryJun 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD CHRONIC DISLOCATION, CONVERTED TO ESC LINER. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25448311 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO JOINT INFECTION AND DISLOCATION, SCREW WAS REMOVED AND HEAD AND POLY WERE CHANGED FOR DUAL MOBILITY CONSTRUCT. ALL PARTS WERE INTACT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 25149505 ↗
• InjuryMay 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIP REVISED BECAUSE OF DISLOCATION. HEAD WAS REMOVED AND REPLACED WITH LONGER OPTION. ORIGINAL DATE OF SURGERY WAS UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25094646 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMORAL HEAD AND LINER WERE REMOVED AND REPLACED WITH A CERAMIC HEAD AND POLY LINER BECAUSE OF ELEVATED METAL ION LEVELS AND A GREATER TROCH FRACTURE. ORIGINAL DATE OF SURGERY IS UNKNOWN. AFFECTED SIDE-UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 24897227 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT CORAIL PINNACLE SECTOR ULTAMET RIGHT WAS IMPLANTED IN 2010. IT WAS REPORTED PATIENT HAD METALOSIS. PATIENT WAS REVISED. ONLY THE ULTAMET INSERT AND HEAD WERE REMOVED.

  Patient problems: Foreign Body Reaction

  MAUDE report 24895417 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SIGNS OF INFECTION. THE HEAD WAS REMOVED, PATIENT HAD I&D, AND NEW HEAD WAS IMPLANTED. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24819456 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTICULEZE M HEAD 36MM +5, PINNACLE MTL INS NEUT36IDX50OD, AND UNKNOWN HIP FEMORAL STEM WERE INVOLVED IN AN EVENT. THE DEPUY METAL HEAD AND METAL LINER WERE REVISED AND REPLACED WITH A POLYETHYLENE LINER AND CERAMIC HEAD. THE PATIENT EXPERIENCED HIGH LEVELS OF METAL IONS AND TRUNIONOSIS, WHICH LED TO THE REVISION PROCEDURE. THERE WAS NO DELAY IN THE CASE. AFFECTED SIDE: RIGHT.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 24578286 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP DUE TO AN INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24507988 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALTRX NEUT 36IDX52OD, PINN SECTOR W/GRIPTION 52MM, AND ARTICULEZE M HEAD 36MM +5 WERE INVOLVED IN A REPORTED EVENT. THE EVENT INVOLVED LINER DISASSOCIATION, RESULTING IN REVISION SURGERY. THE PATIENT EXPERIENCED JOINT INSTABILITY AND REQUIRED A CORRECTIVE INVASIVE PROCEDURE, INCLUDING PRE-OPERATIVE X-RAY AND REPLACEMENT OF THE LINER AND HEAD. THE CUP REMAINED IN SITU WHILE THE LINER AND HEAD WERE EXPLANTED AND RETURNED FOR INVESTIGATION.

  Patient problems: Joint Laxity

  MAUDE report 24481972 ↗
• InjuryJan 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE HIP DISLOCATIONS. HEAD AND LINER WERE REVISED TO A CONSTRAINED LINER. DOI: (B)(6) 2006. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24189154 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH ELEVATED, AND INCREASING LEVELS OF METALLOSIS. SURGEON CHOSE TO REMOVE MOM COMPONENTS AND REPLACE WITH POLY AND CERAMIC CONSTRUCT. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 23896428 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS HIP REVISION DUE TO METALLOSIS. METAL LINER AND HEAD WERE REMOVED AND THOROUGH WASHOUT IN PREVIOUS SURGERY. OVER THE LAST FIVE TO SIX MONTHS PATIENT HAS HAD CHRONIC ISSUES WITH DISLOCATIONS. NEW REVISION CONVERTING HIP TO DUAL MOBILITY WAS DETERMINED TO BE NEEDED TO SOLVE PATIENT DISLOCATIONS. DOI: (B)(6) 2009. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP. THIS REPORT CAPTURES THE SURGERY NEEDED TO ADDRESS THE METALLOSIS. THE ADDITIONAL REVISION NEEDED DUE TO DISLOCATIONS IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Foreign Body Reaction

  MAUDE report 23895834 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 23679618 ↗
• InjuryNov 18, 2025Naturally Worn; Naturally Worn

  PATIENT UNDERWENT REVISION SURGERY FOR METAL ON METAL PINNACLE / TRILOCK FRETTING CAUSING PSEUDO TUMOR. REMOVAL OF METAL LINER AND METAL HEAD WAS DONE WITH REPLACEMENT TO POLY LINER AND TS CERAMIC HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23586739 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAINFUL HIP. DOI: (B)(6) 2009, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23286139 ↗
• InjurySep 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS A HISTORY OF FALL WITH REPEATED DISLOCATIONS. HEAD AND LINER EXCHANGE WAS PERFORMED. CUP & LINER ARE NON-DEPUY PRODUCTS. PREVIOUS REVISIONS WERE TREATED NON-SURGICALLY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23039391 ↗
• InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD AND LINER EXCHANGE DUE TO DISLOCATED HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22804010 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION AND ELEVATED CHROMIUM COBALT LEVELS WITHIN BLOOD. REMOVED METAL LINER AND HEAD WITH COMPLETE WASHOUT AND DEBRIDEMENT OF HIP. DOI: (B)(6) 2009, DOR: (B)(6) 2025 , AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology; Unspecified Infection

  MAUDE report 22798038 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 22797666 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME IN 2006 PATIENT RECEIVED A METAL-ON-METAL HIP REPLACEMENT. CUP BECAME LOOSE AND WAS REVISED WITH NON- DEPUY IMPLANTS. SOFT TISSUE WAS BLACK IN SOME AREAS. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 22752339 ↗