DURALOC 1249-48-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295019749), received between Aug 23, 2017 and Jan 30, 2024 — classified as 8 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 18607994 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN DUE TO WORN POLY. NO PAST REVISION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12869114 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS ECCENTRIC POLY WEAR OF DURALOC LINER; SURGEON REVISED WITH NEW DURALOC POLY. ENDURANCE CEMENTED STEM LOOSENED INTRA-OPERATIVELY WHILE ATTEMPTING TO DISLOCATE FEMORAL HEAD. SURGEON STATED HE DID NOT THINK THE STEM WAS LOOSE BEFORE THE PROCEDURE. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8651192 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 1992; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7796793 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT'S HIP REVISED DUE TO PAIN. A NEW DURALOC POLY 28X48 NEUTRAL WAS CEMENTED INTO THE ACETABULAR SHELL DUE TO SOME METAL WEAR ON THE INSIDE OF CUP. CUP WAS WELL FIXED THOUGH SURGEON FELT PRIOR CUP LOCKING MECHANISM MAY HAVE BEEN COMPROMISED DUE TO THE METAL WEAR ON THE INSIDE OF THE CUP. UNKNOWN HOW METAL WEAR OCCURRED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7391744 ↗
• InjuryJan 9, 2018Fracture; Fracture

  PATIENT WAS REVISED TO ADDRESS METALLOSIS DUE TO BROKEN LOCKING RING, WORN AND LOOSE POLY LINER.DOI: (B)(6) 1998; DOR: DEC 12, 2017; LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 7175014 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS PAIN, IT WAS ALSO INDICATED THAT LINER WAS VERY WORN. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Pain

  MAUDE report 7006806 ↗
• InjuryAug 23, 2017Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION FROM MALPOSITIONING OF THE CUP. IT WAS ALSO INDICATED THAT THE SUPERIOR WEAR ON LINER, HEAD BALL WAS CHANGED.

  Patient problems: No Information

  MAUDE report 6814133 ↗