DURALOC 1220-36-458Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM MARATHON POLYETHYLENE ACETABULAR LINER +4 NEUTRAL 36mm ID 58/70mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295015710), received between Jan 31, 2019 and Sep 15, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Naturally Worn” (2 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
- Adverse Event Without Identified Device or Use Problem4
- Naturally Worn2
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information2
- Joint Laxity2
- No Code Available2
- Pain2
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT CAME WITH STABILITY AND STEM REVISED FOR THIGH PAIN. 58 DURALOC LINER +4 N REPLACED AS WELL AS LOCKING RING. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity; Pain
MAUDE report 23058550 ↗InjuryMar 1, 2024Naturally Worn; Naturally Worn
PATIENT HAD POLY WEAR. SURGEON RETAINED STEM AND CUP. HEAD AND LINER WERE EXCHANGED. NO RECORDS OF THE IMPLANTS OR WHEN ORIGINAL WAS DONE. A 26 +4 HEAD AND A 26 X 58 DURALOC LINER REMOVED. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP
Patient problems: Insufficient Information
MAUDE report 18815786 ↗InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAINFUL HIP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2024; AFFECTED SIDE- UNKNOWN HIP.
Patient problems: Pain
MAUDE report 18808953 ↗InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO STABILITY ISSUES AND THE HEAD/LINER WERE CHANGED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 17395585 ↗InjuryApr 5, 2023Naturally Worn; Naturally Worn
PATIENT WAS REVISED DUE TO WORN POLY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 16684024 ↗InjuryFeb 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8378117 ↗InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD POLYETHYLENE EXCHANGE FOR EARLY INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8292557 ↗
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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