DURALOCRecalls & reported problems across all models
Depuy International Ltd · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 5 models of DURALOC by Depuy International Ltd in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2019 and Jul 3, 2025 — classified as 11 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DURALOC problems
Device problems
- Naturally Worn20
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Material Disintegration1
Patient problems
- Insufficient Information11
- No Code Available4
- Pain3
- Cyst(s)1
- Inflammation1
- Joint Dislocation1
- No Consequences Or Impact To Patient1
- Unspecified Infection1
DURALOC models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DURALOC 1599-23-048Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- DURALOC 1599-23-052Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- DURALOC 1599-23-054Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- DURALOC 1599-23-058Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- DURALOC 1599-23-062Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent DURALOC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 3, 2025Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC HIP-INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR RIGHT SIDE. DOI: 2005. DOR: PLANNED TO TAKE PLACE AS SOON AS POSSIBLE. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.
Patient problems: Insufficient Information
MAUDE report 22395050 ↗InjuryFeb 11, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT SURGEON IS ORDERING A PATIENT SPECIFIC HIP-INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED WEAR. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY. DOI: 2002. DOR: PLANNED TO TAKE PLACE AS SOON AS POSSIBLE. SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21356023 ↗InjuryMay 20, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CLARIFY WHAT BONE INJURY WAS PRESENT? ARTHRO-SYNOVIAL CYSTS RELATED TO PE WEAR. OPPOSITE THE GREATER TROCHANTER AND ON THE ANTERIOR SURFACE OF THE HIP LESS SIGNIFICANTLY BELOW THE INGUINAL LINE.
Patient problems: Cyst(s); Unspecified Tissue Injury
MAUDE report 19351925 ↗InjuryFeb 6, 2024Naturally 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. DOI: 2004. DOR: PLANNED AS SOON AS PATIENT SPECIFIC IMPLANT WILL BE MANUFACTURED BY DEPUY IN SPRING 2024. LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 18649905 ↗InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS PREVIOUSLY REVISED DUE TO BROKEN CERAMIC ON CERAMIC BEARING TO POLY LINER. EVERYTHING REMOVED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT.
Patient problems: Unspecified Infection
MAUDE report 18136839 ↗InjuryOct 19, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT DURALOC OPTION SHELL WAS REVISED FOR POLY WEAR. REPLACEMENT LINERS WERE UNAVAILABLE. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2004. FOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17964402 ↗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 ↗MalfunctionDec 27, 2022Naturally Worn; Naturally Worn
DURALOC OPTION CUP LINER FAILURE. REVISION PENDING.
Patient problems: Insufficient Information
MAUDE report 16050662 ↗MalfunctionDec 22, 2022Naturally Worn; Naturally Worn
DURALOC OPTION CUP LINER FAILURE. REVISION REQUIRED.
Patient problems: Insufficient Information
MAUDE report 16034747 ↗InjuryDec 13, 2022Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC PE INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR LEFT SIDE. DOI: (B)(6) 2003. DOR: PLANNED AS SOON AS PATIENT SPECIFIC IMPLANT WILL BE MANUFACTURED BY DEPUY IN 2023. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.
Patient problems: Insufficient Information
MAUDE report 15968525 ↗InjuryAug 11, 2022Naturally Worn; Naturally Worn
INLAYWECHSEL TO DURALOC OPTION / CONTINUUM CARE PROCESS NECESSARY, PLANNED SURGERY (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 15209409 ↗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 ↗MalfunctionSep 30, 2021Naturally Worn; Naturally Worn
MalfunctionDec 15, 2020Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC DURALOC HIP INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR LEFT SIDE. DOI: (B)(6) 2003, DOR: (PLANNED) 2021. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.
Patient problems: Insufficient Information
MAUDE report 11009323 ↗
Other Depuy International Ltd products
All Depuy International Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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