DURALOC 1599-23-058Recalls & reported problems
Depuy International Ltd · Duraloc OPTION CUP Enduron Liner LPW 28mmID 58 OR 60mmOD · Class 2 · Implant
All models of DURALOC (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295065678), received between Dec 13, 2022 and May 20, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Naturally Worn” (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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn3
Patient problems
- Insufficient Information2
- Cyst(s)1
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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