DURALOC 1241-46-526Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM ENDURON BANTAM ACETABULAR LINER 10 DEGREE 22.225mm ID 46mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295019008), received between Jan 31, 2019 and Mar 25, 2024 — classified as 9 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (14 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 Worn14
- Device-Device Incompatibility2
- Device Dislodged or Dislocated1
- Difficult to Insert1
Patient problems
- Insufficient Information10
- No Code Available3
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SZ 46 ENDURON LINER IS WORN, NEED TO BE REPLACED.
Patient problems: Insufficient Information
MAUDE report 18968623 ↗InjuryMar 21, 2024Naturally Worn; Naturally Worn
SZ 46 ENDURON LINER IS WORN, NEEDS TO BE REPLACED. THE IMPLANT WAS NOT EXPLANTED FROM THE PATIENT, WAITING FOR THE PRODUCTION OF CUSTOM MADE IMPLANTS.
Patient problems: Insufficient Information
MAUDE report 18956392 ↗InjuryNov 20, 2023Naturally Worn; Naturally Worn
InjuryOct 24, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DURALOC LINER IS WORN. ADDITIONAL EVENT INFORMATION PROVIDED BY SALES REP STATES THAT PATIENT WILL BE REVISED IN THE FUTURE, ONCE THE CUSTOM MADE IMPLANT IS DELIVERED. THE LINER WHICH HAS TO BE REPLACED IS WORN WHICH CAUSED PAIN IN THE JOINT.
Patient problems: Pain
MAUDE report 17996811 ↗MalfunctionJun 26, 2023Naturally Worn; Naturally Worn
IT WAS REPORT THAT THE LINER WAS WORN.
Patient problems: Insufficient Information
MAUDE report 17201365 ↗InjuryMar 10, 2023Naturally Worn; Naturally Worn
THE DURALOC LINER IS WORN, NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16522615 ↗MalfunctionMar 8, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT DURALOC LINER IS WORN, NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504330 ↗InjuryJan 6, 2023Naturally Worn; Naturally Worn
DURALOC LINER IS WORN, REPLACEMENT IS NEEDED.
Patient problems: Insufficient Information
MAUDE report 16114146 ↗InjuryJul 28, 2022Naturally Worn; Naturally Worn
ENDURON LINER IS WORN, NEED TO BE REPLACED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO.
Patient problems: Insufficient Information
MAUDE report 15120998 ↗MalfunctionJun 6, 2022Naturally Worn; Naturally Worn
THE LINER IS WORN. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: Insufficient Information
MAUDE report 14603321 ↗MalfunctionMay 20, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE LINER IS WORN OUT.
Patient problems: Insufficient Information
MAUDE report 14452846 ↗MalfunctionApr 7, 2022Naturally Worn; Naturally Worn
DURALOC ENDURON LINER IS WORN, NEED TO BE REPLACED. DOI: (B)(6) 2013.
Patient problems: Insufficient Information
MAUDE report 14042877 ↗MalfunctionFeb 16, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DURALOC ENDURON LINER IS WORN.
Patient problems: Insufficient Information
MAUDE report 13542370 ↗InjuryJun 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION AND INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2019. LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8682730 ↗InjuryApr 8, 2019Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC PE-HIP INLAY LEFT SIDE BECAUSE OF NORMAL PE WEAR. INITIAL SURGERY TOOK PLACE IN ANOTHER HOSPITAL, AN IMPLANT PASSPORT IS NOT EXISTING.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 8493318 ↗MalfunctionFeb 12, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT A DURALOC 300 SERIES SHELL (46MM OD 124646000) WAS IMPLANTED WITH THE LINER 123906000 (NEUTRAL 22.225MM ID X 46MM OD). THERE WAS A NEED TO CHANGE THE LINER RECENTLY AND OUR SALES ASSOCIATE HAD BROUGHT IN THE 10 DEGREE BANTAM LINER (124146526) AND THE LOCKING RING (124946503) THAT GOES WITH IT. THESE HOWEVER WOULD NOT FIT IN THE 300 SERIES CUP. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8331101 ↗MalfunctionJan 31, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility
46MM DURALOC LINER DID NOT FIT IN 46MM DURALOC SHELL.
Patient problems: No Code Available
MAUDE report 8294091 ↗
Other PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED devices
- TEMA Elbow 1590.15.010Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented2 recalls3 reports
- TEMA Elbow 1590.15.020Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented1 recall1 report
- Latitude™ - Elbow DKY068Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED20 reports
- Latitude™ - Elbow DKY067Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED8 reports
- RHS - RADIAL PROSTHESIS DTJ302Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED6 reports
- Latitude™ - Elbow DKY082Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY216Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- CRF II - RADIAL PROSTHESIS DTJ022Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 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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