DURALOC 1245-80-051Recalls & reported problems
Depuy (Ireland) · DURALOC SHELL SECTOR 56mm OD CEMENTLESS · Class 2 · Implant
All models of DURALOC (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295019602), received between Oct 10, 2018 and Jun 25, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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 Problem2
- Osseointegration Problem1
- Positioning Problem1
Patient problems
- No Code Available2
- Inadequate Osseointegration1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD HIP INSTABILITY, 56 DURALOC CUP,56 10 DEGREE LINER, 56 DYNAMIC LOCKING RING, 28 +0 11/13 S-ROM HEAD REMOVED. NO DELAY IN CASE WHILE REMOVING OLD COMPONENTS. DOI- UNKNOWN, DOR- ON (B)(6) 2024, AFFECTED SIDE- LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 19606301 ↗InjurySep 8, 2021Osseointegration Problem; Osseointegration Problem
COMPASS CASE (B)(4) REPORT: REVISION WAS DONE FOR POLY WEAR, DISLOCATION. LOOSENING INTERFACE: NON-CEMENTED.
Patient problems: Inadequate Osseointegration
MAUDE report 12440800 ↗InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO HIP PAIN. DOI: (B)(6) 2002, DOR: (B)(6) 2020, AFFECTED SITE: UNKNOWN.
Patient problems: No Code Available; Pain
MAUDE report 10201079 ↗InjuryOct 10, 2018Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING.
Patient problems: No Code Available
MAUDE report 7951008 ↗
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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