DURALOC 1249-54-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295019770), received between Aug 29, 2017 and Feb 12, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HEAD AND LINER DUE TO INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 18685859 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP PAIN / POLY WEAR. HEAD, LINER, AND LOCKING RING EXCHANGED. ORIGINAL DATE OF SURGERY UNKNOWN. BELIEVED TO BE ABOUT 15 YEARS AGO. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16111836 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 10206940 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 9819527 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS WORN POLY/PAINFUL. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9792945 ↗
• InjuryApr 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT HIP REPLACEMENT. REVISION NOTES REPORTED A DISLODGE POLYETHYLENE LINER. A BROKEN POLY LINER AS WELL AS A BROKEN WELL-FIXED SHELL AND A WELL-FIXED FULL COAT STEM IN APPROPRIATE VERSION AND FROZEN SECTION WAS NEGATIVE FOR ACUTE INFLAMMATION. IT WAS NOTED THAT THE ACETABULAR SHELL ITSELF WAS BROKEN ON THE ANTERIOR ASPECT OF IT. A SIGNIFICANT AMOUNT OF METALLOSIS WAS ALSO NOTED. DOI: (B)(6) 2009 - DOR: (B)(6) 2011, (RIGHT HIP).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8473545 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8043563 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND WORN POLY LINER. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7845764 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 1999; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7808529 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD A POLY LINER AND FEMORAL HEAD REVISION TODAY FOR PAINFUL RIGHT HIP THAT WAS DONE 20 YEARS AGO. DOI: 1998; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7588213 ↗
• InjuryNov 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP DUE TO WORN POLY. ORIGINAL IMPLANT DATE UNKNOWN.

  Patient problems: Pain

  MAUDE report 7064631 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 7047962 ↗
• InjuryAug 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT UNDERWENT A THA 16 YEARS AGO. IT IS ALSO STATED THAT THE X-RAYS SHOW SOME WEAR. UPDATE 8/21/2017 REVIEW OF MEDICAL RECORDS INDICATE REVISION FOR POLYETHYLENE BEARING WEAR, PAIN, AND BURSITIS/SOFT TISSUE INFLAMMATION/REACTIVE WEAR DEBRIS TISSUE. HARMS ADDED. COMPLAINT UPDATED ON: 8/28/2017

  Patient problems: Irritation; Pain; Synovitis

  MAUDE report 6827748 ↗