DURALOC 1220-36-456Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295015703), received between Sep 18, 2018 and Jul 26, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19838981 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A KNOWN INFECTION. I&D WITH HEAD AND LINER WAS PERFORMED. THERE WERE NO DELAYS. NO COMPLAINTS ABOUT THE PRODUCTS. UNKNOWN SURGICAL DELAY. NO OTHER INFORMATION AVAILABLE. DOI: (B)(6) 2013. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19600702 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PSEUDO TUMOR AND CORROSION AT THE HEAD NECK TAPER JOINT. REVISION WAS PERFORMED DUE TO PRESENCE OF SAID PSEUDO TUMOR AND CORROSION WITH ELEVATED METAL ION LEVELS. A HEAD AND LINER SWAP WAS PERFORMED. STEM AND CUP WERE ORIGINALLY IMPLANTED ON (B)(6) 1997. THE FIRST REVISION WAS DONE ON 2015 DUE TO POLY WEAR AND THIS WAS THE SECOND REVISION. NO IMPLANT RECORDS FOR THE STEM, CUP OR HEAD. DOI: (B)(6) 1997 - STEM AND CUP, DOI: (B)(6) 2015 - HEAD AND LINER, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 10323769 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION I & D. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10320847 ↗
• InjuryNov 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8089785 ↗
• InjurySep 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL HIP REPLACEMENT WAS DONE SOMETIME IN 2000 BUT SURGEON AND FACILITY IS UNKNOWN. RECURRENT DISLOCATION RIGHT HIP, THE CUP AND HEAD WERE EXCHANGED IN 2014 DUE TO CUP WAS VERTICAL AND THERE WAS SOME ECCENTRIC WEAR OF THE POLY. PATIENT AGAIN HAD MULTIPLE DISLOCATIONS. DOI: (B)(6) 2014; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7886675 ↗