DURALOC 1599-23-048Recalls & reported problems
Depuy International Ltd · Duraloc OPTION CUP Enduron Liner LPW 28mmID 48 OR 50mmOD · Class 2 · Implant
All models of DURALOC (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295065647), received between Jun 4, 2020 and Nov 14, 2023 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (8 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 Worn8
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information4
- No Code Available3
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗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 ↗InjuryNov 16, 2020Naturally Worn; Naturally Worn
CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS POLYETHYLENE LINER WEAR. DATE OF IMPLANTATION: (B)(6) 2005. DATE OF REVISION: (B)(6) 2020; (RIGHT HIP). TREATMENT: ACETABULAR LINER AND FEMORAL HEAD WERE REVISED.
Patient problems: No Code Available
MAUDE report 10843065 ↗MalfunctionOct 15, 2020Naturally Worn; Naturally Worn
MalfunctionJun 4, 2020Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC HIP INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR RIGHT SIDE. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.
Patient problems: No Code Available
MAUDE report 10119098 ↗
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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