DURALOC 1245-80-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295019633), received between Oct 23, 2019 and Oct 31, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 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 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  EXCESSIVE WEARING OF POLYETHYLENE AND MOBILIZATION OF THE RIGHT HIP CUP OF THE ACETABULAR COMPONENT INSERT AND CERAMIC HEAD.

  Patient problems: Insufficient Information

  MAUDE report 18039912 ↗
• 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 10191090 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT HIP. THE SURGEON REMOVED A DURALOC CUP AND LINER AND REPLACED WITH A COMPETITIVE IMPLANT. HEAD BALL WAS REMOVED AND REPLACED. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10138401 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF DPS IMPLANTS DUE TO INFECTION. STEM, HEAD, LINER, AND CUP WAS REMOVED. SPACER WAS IMPLANTED WHILE INFECTION IS TREATED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9490917 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, THE PATIENT ALLEGES WEAR, METAL DEBRIS, PSEUDOTUMOR, SOFT TISSUE REACTION: ALTR, ARMD, METALLOSIS, AND ALVAL.

  Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Hypoesthesia; Hyporesponsive to stimuli; Neuropathy; No Code Available; Pain; Rash; Swelling/ Edema; Unspecified Tissue Injury; Weight Changes

  MAUDE report 9224421 ↗