DURALOC 1220-36-554Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295015765), received between May 24, 2018 and May 6, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON REVISED THIS A COUPLE OF MONTHS AGO, THE PATIENT WAS REVISED AGAIN BECAUSE OF HIP DISLOCATION. HE DECIDED TO REMOVE THE CUP LINER AND HEAD AND REPLACED WITH A STRYKER MDM CUP WITH OUR BALL TO HELP CORRECT THE PATIENTS DISLOCATION PROBLEMS. I DO NOT HAVE THE DATE OR PRODUCT NUMBER OF THE ORIGINAL CASE WHEN THE CUP WAS FIRST IMPLANTED. DOI: (B)(6) 2020 (HEAD AND LINER); DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10030730 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 9819511 ↗
• InjuryApr 2, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT HIP REPLACEMENT. REVISION NOTES REPORTED A DISLODGE POLYETHYLENE LINER. A BROKEN POLY LINER AS WELL AS A BROKEN WELL-FIXED SHELL AND A WELL-FIXED FULL COAT STEM IN APPROPRIATE VERSION AND FROZEN SECTION WAS NEGATIVE FOR ACUTE INFLAMMATION. IT WAS NOTED THAT THE ACETABULAR SHELL ITSELF WAS BROKEN ON THE ANTERIOR ASPECT OF IT. A SIGNIFICANT AMOUNT OF METALLOSIS WAS ALSO NOTED. DOI: (B)(6) 2009; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8473539 ↗
• InjuryJul 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HEAD AND LINER EXCHANGE. REASON FOR REVISION UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 7685202 ↗
• InjuryMay 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT: (B)(6). CLINICAL DATABASE NOTIFICATION OF REVISION OF THE FEMORAL HEAD AND LINER DUE TO INFECTION WAS RECEIVED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; (RIGHT HIP).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7540293 ↗