DURALOC 1249-60-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295019800), received between Sep 22, 2017 and Feb 22, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO DELAYS AND NO HARM TO THE PATIENT. DOI: UNKNOWN, DOR: (B)(6), 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 18762976 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED WITH RIGHT TOTAL HIP DUE TO PAIN RELATING TO FALLING. THE HEAD AND LINER WAS EXCHANGED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Pain

  MAUDE report 18630140 ↗
• MalfunctionFeb 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE STERILE PACKAGING HAS SUSPECTED BREAK IN THE SEAL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432223 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6), 2021 DOR: (B)(6), 2021 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11649231 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10303085 ↗
• 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, LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10210576 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10191448 ↗
• InjuryMar 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND SUSPECTED METALLOSIS FROM CABLES OR STEM TRUNNION. SURGEON FOUND NO SIGNS OF METALLOSIS BUT FOUND A LARGE HEMATOMA. SURGEON CLEANED OUT THE WOUND AND REPLACED THE HEAD (COMPETITOR), LINER AND LOCKING RING. DOI: UNKNOWN; DOR: (B)(6) ,2018; RIGHT HIP.

  Patient problems: Hematoma; Not Applicable; Pain

  MAUDE report 7377123 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND POLYWEAR.

  Patient problems: Pain

  MAUDE report 7074308 ↗
• 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 6886889 ↗