NA 1018-36-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295001393), received between Sep 22, 2017 and Apr 17, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC DISLOCATIONS. REVISED THE DEPUY HEAD AND COMPETITOR LINER TO CONSTRAINED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21855241 ↗
• InjuryMay 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED. PUT IN A NEW CUP AND HEAD. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11848454 ↗
• InjuryMay 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION. DOI: (B)(6) 2000, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11793993 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9898291 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE-REVISION OF A RIGHT HIP PATIENT HAS A TOTAL HIP ON THE LEFT SIDE AND A SOLUTION/DURALOC ON THE RIGHT SIDE THAT WAS IMPLANTED 32 YEARS AGO. REASON FOR THE REVISION WAS POLY WEAR. DURING THE SURGERY, THE SURGEON ASSESSED THE STABILITY OF THE SOLUTION STEM AND DECIDED NOT TO REMOVE. THE AML TAPER 28MM +3 COCR HEAD, THE DURALOC SECTOR CUP SIZE 56, THE POLY LINER AND 2 SCREWS WERE EXPLANTED WITHOUT ISSUES. THE SURGEON IMPLANTED A ZIMMER BIOMET CONTINUUM CUP SIZE 58 WITH A 36MM I.D. LINER AND 3 SCREWS. HE ALSO IMPLANTED A DEPUY COCR LARGE TAPER HEAD 36MM +8. NO WEAR WAS OBSERVED ON THE TRONION PRIOR TO RE-ATTACH OF THE FEM. HEAD.

  Patient problems: No Code Available

  MAUDE report 9601599 ↗
• InjuryMay 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED TWO TIMES AFTER LAST REVISION CASE, SO WENT BACK IN AND CHANGED THE POSITION OF THE LIP ON THE LINER AND MOVED TO A +8 HEAD TO A +11 LARGE TAP HEAD. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8636539 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR ON A COMPETITOR CUP.

  Patient problems: No Code Available

  MAUDE report 8185089 ↗
• InjuryNov 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: DER STATES METALOSIS/TRUNIONOSIS, PAIN, ELEVATED METAL ION LEVELS.

  Patient problems: Foreign Body Reaction; Pain; Tissue Damage

  MAUDE report 7010509 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS CHRONIC INFECTION. THE SURGEON DID A LINER AND HEAD EXCHANGE WITH AN I&D.

  Patient problems: Unspecified Infection

  MAUDE report 6886883 ↗