DURALOC 1245-80-055Recalls & reported problems
Depuy (Ireland) · DURALOC SHELL SECTOR 48mm OD CEMENTLESS · Class 2 · Implant
All models of DURALOC (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295019640), received between May 1, 2018 and Jul 1, 2024 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Defective 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
- Defective Device1
- Fitting Problem1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- No Consequences Or Impact To Patient2
- Foreign Body Reaction1
- No Code Available1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE HIP CONSTRUCT FRACTURE: SILENT HIP STEM, DURALOC CUP, ENDURON LINER, COCR FEMORAL HEAD. HIP REVISION IS REQUIRED.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 19644212 ↗MalfunctionJan 7, 2020Defective Device; Defective Device
SIZE ISSUE. IT WAS REPORTED THAT DURING THE SURGERY OF TOTAL HIP ARTHROPLASTY, USED 48#TRIAL, IT WAS OK, BUT 48#IMPLANT, IT WAS SMALL. USED 50# TO COMPLETE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER SURGERY, THE CUSTOMER MEASURED THE TRIAL AND IMPLANT, FOUND THE IMPLANT WAS SMALLED THAN TRIAL AS THE PHOTOS SHOW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9560204 ↗MalfunctionJan 22, 2019Fitting Problem; Fitting Problem
DURALOC 48MM ACETABULAR DID NOT GIVE THE PRESS FIT NEEDED FOR FIXING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8266683 ↗InjuryNov 29, 2018Fracture; Fracture
DURING REVISION OF RIGHT INLAY BECAUSE OF NORMAL WEAR A FRACTURED LOCKING RING WAS FOUND. DOI: (B)(6) 2002, DOR (B)(6) 2018. RIGHT HIP.
Patient problems: No Code Available
MAUDE report 8114793 ↗InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 7475267 ↗
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.
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