DURALOC 1599-23-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295065661), received between Feb 5, 2019 and Jan 4, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2023Naturally Worn; Naturally Worn

  MANUFACTURE OF CUSTOM-MADE DURALOC OPTION CUP IMPLANTS DUE TO BEING A DISCONTINUED PRODUCT AND THE NEED TO REVIEW THE PROSTHESIS PLACED ON THE PATIENT FOR LONGEVITY.

  Patient problems: Insufficient Information

  MAUDE report 16093756 ↗
• MalfunctionMay 23, 2022Naturally Worn; Naturally Worn

  POLYETHYLENE HAS NORMAL WEAR. REVISION IS PLANNED AND WILL BE CONDUCTED ONCE PATIENT SPECIFIC IMPLANT IS MANUFACTURED BY DEPUY. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.

  Patient problems: Insufficient Information

  MAUDE report 14479575 ↗
• MalfunctionMar 29, 2022Naturally Worn; Naturally Worn

  SURGEON IS ORDERING A PATIENT SPECIFIC PE INLAY FOR A PLANNED REVISION BECAUSE OF PAIN AND PE-WEAR RIGHT SIDE. DOI: 2001. DOR: PLANNED AS SOON AS PATIENT SPECIFIC IMPLANT WILL BE MANUFACTURED BY DEPUY IN (B)(6) 2022. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.

  Patient problems: Pain

  MAUDE report 13937669 ↗
• InjuryFeb 5, 2019Material Disintegration; Device Dislodged or Dislocated; Naturally Worn; Material Disintegration; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THE SURGEON IS ORDERING A PATIENT SPECIFIC DURALOC OPTION INLAY AND A FEMORAL HEAD BECAUSE OF WEAR. IN THE X-RAY DISLOCATION OF THE FEMORAL HEAD IN THE SENSE OF INCREASED PE WEAR WAS SEEN. ALSO, THERE WAS REPORTEDLY MODERATE GROIN PAIN PROBABLY CAUSED BY SYNOVITIS. THE ORIGINAL LEFT SIDE PROCEDURE OCCURRED ON AN UNKNOWN DATE IN 2005. REPORTEDLY A REVISION PROCEDURE IS PLANNED.

  Patient problems: Inflammation; Joint Dislocation; Pain

  MAUDE report 8304298 ↗