DURALOC 1220-28-048Recalls & reported problems
Depuy Orthopaedics, Inc. · Duraloc MARATHON ACETABULAR LINER Neutral 28mm ID 48mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295015055), received between Apr 3, 2018 and Oct 16, 2025 — classified as 5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Naturally Worn2
- Loss of or Failure to Bond1
- Off-Label Use1
Patient problems
- Not Applicable2
- Pain2
- Insufficient Information1
- Joint Dislocation1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC HIP-INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR RIGHT SIDE. DOI: ON (B)(6) 2004. DOR: PLANNED TO TAKE PLACE AS SOON AS POSSIBLE. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.
Patient problems: Insufficient Information
MAUDE report 23311899 ↗InjuryJun 8, 2021Loss of or Failure to Bond; Off-Label Use; Loss of or Failure to Bond; Off-Label Use
IT WAS REPORTED THE PATIENT HAD CEMENTED POLY LINER AND FEMORAL HEAD REPLACED DURING REVISION DUE TO PAIN. CEMENTED POLY LINER WAS FOUND TO BE LOOSE INSIDE ACETABULAR CUP. REVISED WITH ANOTHER CEMENTED POLY INSIDE THE ACETABULAR COMPONENT AND A NEW FEMORAL HEAD. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT HIP.
Patient problems: Pain
MAUDE report 11962585 ↗InjurySep 4, 2019Naturally Worn; Naturally Worn
THE PATIENT WAS REVISED DUE TO ECCENTRIC POLY WEAR ON ACETABULAR LINER. DOI: (B)(6)1995. DOR: (B)(6) 2019. LEFT HIP.
Patient problems: No Code Available
MAUDE report 8958792 ↗InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS DISLOCATION. A NEW POLY AND HEAD WERE IMPLANTED TO HELP WITH STABILITY. DOI: 2000; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Joint Dislocation; Not Applicable
MAUDE report 7398810 ↗InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATES THAT THE PATIENT'S HIP REVISED DUE TO PAIN. A NEW DURALOC POLY 28X48 NEUTRAL WAS CEMENTED INTO THE ACETABULAR SHELL DUE TO SOME METAL WEAR ON THE INSIDE OF CUP. CUP WAS WELL FIXED THOUGH SURGEON FELT PRIOR CUP LOCKING MECHANISM MAY HAVE BEEN COMPROMISED DUE TO THE METAL WEAR ON THE INSIDE OF THE CUP. UNKNOWN HOW METAL WEAR OCCURRED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: Not Applicable; Pain
MAUDE report 7391755 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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