DURALOC 1220-28-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295015208), received between Jan 5, 2018 and Mar 9, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POLYETHYLENE WEAR OF THE RIGHT-SIDE INLAY FOLLOWING HIP SURGERY. PATIENT OUTCOME IS REPORTED AS FULLY RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 24547452 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP: A. WAS THERE ANY SURGICAL DELAY ? -NO SURGICAL DELAY. B. WHAT WERE THE ALLEGATION AGAINST THE CUP AND HEAD WHY THEY WERE REVISED ? -THE CUP AND LINER WERE REVISED DUE TO POLY WEAR OVER TIME. IT WAS SUSPECTED DUE TO POOR POSITIONING OF COMPONENTS. C. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT LED TO THE REVISION SURGERY? - DISLOCATION.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 18245954 ↗
• InjuryJun 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A DURALOC 300 CUP, 58X28 10 DEGREE LIP LINER, AML STEM, AND 28 +8 14/16 FEMORAL HEAD. THE ORIGINAL IMPLANT DATE AND IMPLANTING SURGEON WAS UNKNOWN. PATIENT WAS BEING REVISED DUE TO POLY WEAR OF OLDER POLY AND HIP INSTABILITY. DR OPTED TO REMOVE THE PREVIOUS POLY AND UPSIZE THE PATIENT TO A 32 CONSTRAINED LINER. THE NEW LINER AND FEMORAL HEAD WERE IMPLANTED AND THE HIP WAS REDUCED. HIP WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17038804 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS REMOVAL OF IMPLANTS DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2019. UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8560026 ↗
• InjurySep 20, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLYETHYLENE WEAR. IT WAS ALSO INDICATED THAT THE SURGEON REPLACED THE LINER AND HEAD. DOI: (B)(6) 2005; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7893116 ↗
• InjuryJan 5, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND SOME DIFFICULTY IN MOVING HIS TWO HIPS. BILATERAL HIP SURGERY WAS DONE 16 YEARS AGO. ECCENTRIC POLY WEAR AND OSTEOLYSIS WERE OBSERVED. IT WAS STATED THAT THE SURGEON PERFORMED DEBRIDEMENT AND REPLACED THE HEAD AND LINER. DOI: 16 YEARS AGO; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Osteolysis; Pain

  MAUDE report 7167251 ↗