DURALOC 1599-23-052Recalls & reported problems
Depuy International Ltd · Duraloc OPTION CUP Enduron Liner LPW 28mmID 52mmOD · Class 2 · Implant
All models of DURALOC (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295065654), received between Apr 29, 2020 and Jul 3, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn4
Patient problems
- Insufficient Information2
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗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 ↗MalfunctionSep 22, 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. DOI: (B)(6) 2006, DOR: PLANNED AS SOON AS PART WILL BE MANUFACTURED BY DPS. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.
Patient problems: No Code Available
MAUDE report 10567167 ↗MalfunctionApr 29, 2020Naturally Worn; Naturally Worn
REVISION SURGERY PLANNED FOR THE PATIENT NEEDING TO PRESERVE CUP THAT IS IN SITU CURRENTLY AND PROMOTE BONE PRESERVATION - NEED REPLACEMENT LINER FOR THE CUP. NOTE FROM SALES REP: THE PATIENT NEEDS A LINER REPLACEMENT FOR THE DURALOC OPTION CUP THAT WAS IMPLANTED IN 2004. AT THE DATE OF OPERATION, THE PATIENT WAS (B)(6) AND THE PROCEDURE WAS A REVISION OPERATION. THE PATIENT HAS NOT PRESENTED ANY ADVERSE SYMPTOMS AND THERE IS NO ALLEGED DEFICIENCY WITH THE DEPUY PRODUCT. THE LINER NEEDS TO BE REPLACED AFTER IDENTIFYING SOME WEAR TO THE LINER AS COULD BE EXPECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10010571 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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