DURALOC 1220-36-460Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM MARATHON POLYETHYLENE ACETABULAR LINER +4 NEUTRAL 36mm ID 60/72mm 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 10603295015727), received between Sep 22, 2017 and Feb 22, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
Patient problems
- No Code Available2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hematoma1
- Joint Dislocation1
- Joint Laxity1
- Not Applicable1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO DELAYS AND NO HARM TO THE PATIENT. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 18762979 ↗InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11649223 ↗InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT SIDE.
Patient problems: No Code Available
MAUDE report 10191444 ↗InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP - COMPONENTS APPEARED TO BE WELL FIXED - SURGEON REMOVED HO BONE - HEAD LINER EXCHANGE. DOI: 2003; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.
Patient problems: No Code Available; Pain
MAUDE report 9771303 ↗InjuryMar 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS PAIN AND SUSPECTED METALLOSIS FROM CABLES OR STEM TRUNNION. SURGEON FOUND NO SIGNS OF METALLOSIS BUT FOUND A LARGE HEMATOMA. SURGEON CLEANED OUT THE WOUND AND REPLACED THE HEAD (COMPETITOR), LINER AND LOCKING RING. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Hematoma; Not Applicable; Pain
MAUDE report 7377094 ↗InjuryFeb 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018 RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7285144 ↗InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS CHRONIC INFECTION. THE SURGEON DID A LINER AND HEAD EXCHANGE WITH AN I&D.
Patient problems: Unspecified Infection
MAUDE report 6886903 ↗
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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