DURALOC 1245-80-052Recalls & reported problems
Depuy (Ireland) · DURALOC SHELL SECTOR 58mm OD CEMENTLESS · Class 2 · Implant
All models of DURALOC (23)
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 10603295019619), received between May 22, 2018 and Dec 7, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Migration or Expulsion of Device1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- Joint Laxity1
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT HAD ECCENTRIC WEAR WEAR OF POLY AND WORE THROUGH THE POLY OVER TIME. A CUP REVISION WAS DONE AND THE HEAD WAS SWAPPED. DOI: (B)(6) 2002, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 18284449 ↗InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 12415439 ↗InjuryMay 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT SUBSIDED OVERTIME. LOOSENING AT BONE TO CEMENT INTERFACE AND CEMENT MANUFACTURER IS UNKNOWN. THE SURGEON DETERMINED TOO MUCH ANTEVERSION OF THE CUP AND DECIDED TO REVISE ALL COMPONENTS. DOI: 1998; DOR: (B)(6) 2018; UNKNOWN HIP.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7533266 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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.
How reports and recalls are matched · Editorial policy · Report an error on this page