DURALOC 1249-56-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295019787), received between Jan 10, 2018 and Apr 28, 2025 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION PROCEDURE DUE TO WEAR DUE TO THE LONG IMPLANTATION TIME. THE NEW INLAY WAS INSERTED INTO A CUP THAT HAD ALREADY BEEN IMPLANTED FOR YEARS. WHEN REPLACING THE DURALOC, THE DYNAMIC LOCK RING WAS MISSING. THERE WAS A MISUNDERSTANDING WHEN MAKING THE REQUEST. THE PATIENT HAD TO UNDERGO ANOTHER OPERATION THE NEXT DAY DUE TO THE MISSING LOCK RING. THE PATIENT SUFFERED NO HARM. NO FURTHER CONSEQUENCES HAVE BEEN REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919689 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED AND HAD AN IRRIGATION AND DEBRIDEMENT (I&D) AND HEAD & LINER EXCHANGE. DOI: (B)(6) 2013 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19927405 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIP INSTABILITY, 56 DURALOC CUP,56 10 DEGREE LINER, 56 DYNAMIC LOCKING RING, 28 +0 11/13 S-ROM HEAD REMOVED. NO DELAY IN CASE WHILE REMOVING OLD COMPONENTS. DOI- UNKNOWN, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19606261 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Pain

  MAUDE report 18684437 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16913559 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 16380047 ↗
• InjuryNov 29, 2022Adverse 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) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15877486 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: 30 YEARS AGO, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 12298114 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS PAIN DUE TO A WORN POLY LINER. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10683401 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10212548 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HIP PAIN. DOI: (B)(6) 2002, DOR: (B)(6) 2020, AFFECTED SITE: UNKNOWN.

  Patient problems: No Code Available; Pain

  MAUDE report 10201008 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR. DOI: (B)(6) 2000, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Pain

  MAUDE report 8653423 ↗
• InjuryJan 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED FOR ACUTE DISLOCATION. THE SAME IMPLANTS WERE REIMPLANTED. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION:DISLOCATION ACTION TAKEN FOR PROCEDURE:REVISED LINER AND HEAD FOR DISLOCATION IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7179057 ↗