DURALOC 1242-20-527Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 32mm ID 60/72mm 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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295019251), received between Sep 1, 2020 and Dec 8, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Naturally Worn1
Patient problems
- Joint Dislocation2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2025Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC CONSTRAINED HIP LINER FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY. DOI: > 16 YRS AGO. DOR: PLANNED TO TAKE PLACE AS SOON AS POSSIBLE. AFFECTED SIDE: RIGHT.
Patient problems: Insufficient Information
MAUDE report 23747597 ↗InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A HEAD AND LINER EXCHANGE DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 18085344 ↗InjuryJul 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT REVISED DUE TO DISLOCATION. PREVIOUS CONSTRAINED LINER, SURGEON REPLACED IT. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 17421727 ↗MalfunctionFeb 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THE STERILE PACKAGING HAS SUSPECTED BREAK IN THE SEAL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16432264 ↗InjurySep 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD DISLOCATED HIP, SURGEON EXPLANTED CONSTRAINED LINER REVISING WITH ANOTHER CONSTRAINED LINER. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10477572 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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