NA 1018-14-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295001355), received between Nov 20, 2017 and Nov 18, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS REVISED ON (B)(6). AFTER THAT REVISION, THE PATIENT DISLOCATED. THE SECOND REVISION HAPPENED ON (B)(6), WHERE A CONSTRAINING LINER WAS USED.

  Patient problems: Joint Dislocation

  MAUDE report 23580824 ↗
• InjuryNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. PATIENT DISLOCATED TWICE. DR DECIDED TO CONSTRAIN. THE CUP WAS FINE. IN THIS REVISION, THE DYNAMIC LOCKING RING WAS BENT SO SURGEON TRIED ANOTHER ONE BEFORE PUTTING IN A CONSTRAINED LINER. IT IS UNKNOWN IF IT WAS BENT WHEN IT WAS IMPLANTED, OR AS A RESULT OF THE DISLOCATIONS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP. RELATED COMPLAINT (B)(4) CAPTURES PREVIOUS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 23535978 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING BAD PAIN. NO INFECTION WAS PRESENT. PULLED THE CUP, LINER AND HEAD BALL AND PUT IN A DIFFERENT VENDOR'S IMPLANT. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22054856 ↗
• InjuryAug 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 20063177 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MARCH 25, 2024 THE REMOVAL OF THE 28MM LINER AND HEAD WAS REPLACED WITH A 36 HEAD AND LINER. NOTHING MORE TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19033864 ↗
• InjuryJan 12, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO THE CUP THAT DISLOCATED. DOI: UNKNOWN. DOR: (B)(4) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18501835 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY FOLLOWING REMOVAL OF TUMOR. THERE WAS NO SURGICAL DELAY. DOI: OCTOBER 2, 1992. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17877086 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17833078 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR LEFT HIP REVISION TO ASEPTIC LOOSENING OF THE FEMORAL STEM DATE OF IMPLANTATION: (B)(6) 1988. DATE OF REVISION: (B)(6) 2020. (LEFT HIP) TREATMENT: WERE DEPUY COMPONENTS REMOVED?: YES.

  Patient problems: Unspecified Infection

  MAUDE report 17439306 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DURALOC 300 CUP, 58X28 10 DEGREE LIP LINER, AML STEM, AND 28 +8 14/16 FEMORAL HEAD. THE ORIGINAL IMPLANT DATE AND IMPLANTING SURGEON WAS UNKNOWN. PATIENT WAS BEING REVISED DUE TO POLY WEAR OF OLDER POLY AND HIP INSTABILITY. DR OPTED TO REMOVE THE PREVIOUS POLY AND UPSIZE THE PATIENT TO A 32 CONSTRAINED LINER. THE NEW LINER AND FEMORAL HEAD WERE IMPLANTED AND THE HIP WAS REDUCED. HIP WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17038802 ↗
• InjuryMay 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO DISLOCATION. THE SURGICAL DELAY WAS UNKNOWN. DOR: (B)(6) 2023.

  Patient problems: Joint Dislocation

  MAUDE report 16854389 ↗
• InjuryMay 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION SURGERY, THERE WAS NO SURGICAL DELAY. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? PLEASE REFER TO ADDITIONAL EVENT INFORMATION (B)(4). (B)(4) - CALL LOG WITH (B)(6) 03/06/2021: HE WAS UNABLE TO CONFIRM WHICH WAS THE AFFECTED SIDE, HOWEVER HE ADVISED THAT THE REVISION SURGERY ON (B)(6) 2018 WAS FOR THE SAME SIDE AS THE REVISION SURGERY ON (B)(6) 2021 (CAPTURED IN (B)(4) ).

  Patient problems: Joint Dislocation

  MAUDE report 11841651 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CUP REVISION DUE TO INSTABILITY. HEAD REPLACED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10869950 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN. DOI: (B)(6) 2020 DOR: (B)(6) 2020 RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10852892 ↗
• InjuryNov 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS HIP DISLOCATION DATE OF IMPLANTATION: (B)(6) 1995, DATE OF REVISION: (B)(6) 2006, (RIGHT HIP). TREATMENT: REVISION OF DEPUY FEMORAL HEAD AND COMPETITOR ACETABULAR LINER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10792115 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INSTABILITY ISSUES SO THE SURGEON REMOVED THE CUP AND REPLACED IT WITH A COMPETITOR MDM CUP AND PUT A NEW BALL ON THE SOLUTION STEM. COULD NOT FIND INFO ON THE FIRST SURGERY WHEN AND WHERE IT WAS DONE. COULD NOT LOCATE REF OR PART #S FOR THE CUP THAT WAS REMOVED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10778079 ↗
• InjuryOct 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10726581 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER HIP REPLACED APPROXIMATELY 20 PLUS YEARS AGO AND CAME TO THE ER AT (B)(6) BECAUSE SHE WAS NOT FEELING WELL AND HAD A FEVER OF 103 ACCORDING TO SURGEON. SHE DID NOT REMEMBER WHERE SHE HAD HER HIP REPLACED OR WHO DID THE SURGERY. XRAYS REVEALED THAT THE STEM WAS A 5/8 AML STEM WITH A LARGE TAPER HIP BALL AND A COMPETITOR CUP. PATIENT ALSO HAD AN INFECTION. THE SURGEON DID A THOROUGH I&D AND EXCHANGED OUR HIP BALL. THE AML STEM WAS LEFT IN SITU. NO INFORMATION IS AVAILABLE FOR THE AML LOT NUMBER AND NO LAB REPORTS AVAILABLE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fever; No Code Available; Unspecified Infection

  MAUDE report 10432098 ↗
• InjuryMar 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DOI CUP: (B)(6) 1996; DOI HEAD AND LINER: (B)(6) 2017; DOR: (B)(6) 2019; (LEFT HIP). HEAD, LINER AND CUP REVISED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8421205 ↗
• InjuryFeb 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR WHICH LED TO DISLOCATION CAUSING PAIN.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8302226 ↗
• InjuryApr 26, 2018Naturally Worn; Naturally Worn

  DER STATES THAT THE LINER WAS WORN THAT PRECIPITATED DISLOCATION. IT WAS REPORTED THAT REVISION OF ACETABULAR LINER AND FEMORAL HEAD. THE FEMORAL STEM AND CUP WERE WELL FIXED, DOI: (B)(6) 1998; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7464044 ↗
• InjuryApr 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. SURGEON REMOVED HEAD, LINER, AND LOCKING RING, AND REPLACED WITH DEPUY LINER AND LARGER HEAD. DOI: UNKNOWN DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Not Applicable

  MAUDE report 7442578 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 7044934 ↗