DURALOC 1220-36-562Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 36mm ID 62/74mm OD · Class 2 · Implant
All models of DURALOC (93)
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 10603295015802), received between Jun 12, 2018 and May 6, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem3
- Device Dislodged or Dislocated1
Patient problems
- No Code Available2
- Unspecified Infection2
- Inflammation1
- Joint Dislocation1
- Joint Laxity1
- Not Applicable1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S HEAD AND LINER WERE REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2025 , AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 21970308 ↗InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENTS WAS REVISED TO ADDRESS RIGHT HIP INFECTION. ALL COMPONENTS WERE REMOVED AND A PROSTALAC IMPLANT WAS IMPLANTED. RIGHT HIP.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8574533 ↗InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. WE ARE TAKING OUT POLY AND HEAD. WASHING OUT HIP AND REPLACING THE LINER AND HEAD WITH NEW IMPLANTS. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8330973 ↗InjuryJun 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
DER STATES THAT DURALOC POLY WAS REVISED FOR POLY WEAR AND BROKEN LOCKING RING. THE RING HAD ESCAPED THE SHELL AND WAS FOUND IN THE LATERAL THIGH SOFT TISSUE. WHEN ATTEMPTING TO IMPLANT A NEW LOCKING RING, IT WAS DETERMINED THAT THE DURALOC SHELL WAS A 60, NOT A 62. THE 62 HAD BEEN IMPLANTED ON (B)(6) 2017 BASED ON RETRIEVAL OF A 62 LINER AT THAT TIME. THAT LINER APPARENTLY WAS IMPLANTED ON (B)(6) 2000 AT (B)(6) HOSPITAL IN (B)(6). THE ORIGINAL SURGERY WAS DONE IN (B)(6) AROUND 1995. THE DURALOC SHELL WAS REVISED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP CUP; DOI: UNKNOWN.
Patient problems: Inflammation; Joint Dislocation; Not Applicable
MAUDE report 7591891 ↗
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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