DURALOC 1249-62-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295019817), received between Jun 12, 2018 and Oct 30, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 10765395 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP SUBLUXED MANY TIMES OVER THE PAST COUPLE OF YEARS, BUT LAST WEEK IT FINALLY DISLOCATED COMPLETELY. THEY WERE ABLE TO REDUCE HIM BUT HE DECIDED TO HAVE IT REVISED. NO CORROSION ON THE NECK TAPER AND HEAD JOINT. EVERYTHING WAS WELL FIXED. I DO NOT HAVE THE EXACT DATE THEY WERE ORIGINALLY IMPLANTED IN 2003. DOI: 2003. DOR: (B)(6) 2020; RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10191087 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS WAS REVISED TO ADDRESS RIGHT HIP INFECTION. ALL COMPONENTS WERE REMOVED AND A PROSTALAC IMPLANT WAS IMPLANTED. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8574585 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. WE ARE TAKING OUT POLY AND HEAD. WASHING OUT HIP AND REPLACING THE LINER AND HEAD WITH NEW IMPLANTS. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8330968 ↗
• InjuryJun 12, 2018Fracture; Fracture

  DER STATES THAT DURALOC POLY WAS REVISED FOR POLY WEAR AND BROKEN LOCKING RING. THE RING HAD ESCAPED THE SHELL AND WAS FOUND IN THE LATERAL THIGH SOFT TISSUE. WHEN ATTEMPTING TO IMPLANT A NEW LOCKING RING, IT WAS DETERMINED THAT THE DURALOC SHELL WAS A 60, NOT A 62. THE 62 HAD BEEN IMPLANTED ON (B)(6) 2017 BASED ON RETRIEVAL OF A 62 LINER AT THAT TIME. THAT LINER APPARENTLY WAS IMPLANTED ON (B)(6) 2000 AT (B)(6). THE ORIGINAL SURGERY WAS DONE IN (B)(6) AROUND 1995. THE DURALOC SHELL WAS REVISED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP. CUP DOI: UNKNOWN.

  Patient problems: Inflammation; Not Applicable

  MAUDE report 7591910 ↗