DURALOC 1220-32-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295015482), received between Nov 28, 2018 and Nov 14, 2025 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Naturally Worn; Naturally Worn

  SURGEON IS ORDERING A PATIENT SPECIFIC HIP-INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR LEFT SIDE. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY. THERE IS NO PATIENT CONSEQUENCE. DOR: PLANNED TO TAKE PLACE AS SOON AS POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554719 ↗
• DeathDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXTRACTION OF IMPLANTS FOR INFECTION. IMPLANTS REMOVED WERE A CORAIL NON COLLARED STANDARD 14 STEM AND A 1200 SERIES DURALOC 58MM CUPS WITH A 32 10 DEGREE LINER. PATIENT PASSED AWAY AFTER THE CASE AS A RESULT OF THE INFECTION HE WAS BATTLING. THE PRIMARY SURGERY DATE IS NOT KNOWN, BUT ESTIMATED TO BE 17/18 YEARS AGO. NO FURTHER DETAILS OF THE PRODUCTS INVOLVED WILL BE ABLE TO BE PROVIDED. THE PATIENT WAS VERY SICK PRIOR TO THE REVISION SURGERY AND WAS IN INTENSIVE CARE WITH SEPSIS. WHEN THE HIP WAS OPENED A LARGE VOLUME OF PUS WAS PRESENT. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11055398 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR. DOI: (B)(6) 2005 - DOR: (B)(6) 2007 (RIGHT HIP).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8109950 ↗