DURALOC 1241-14-527Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 28mm ID 54mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295018704), received between Mar 20, 2018 and Apr 27, 2021 — classified as 2 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.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Difficult to Insert1
Patient problems
- Joint Dislocation2
- Fall1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2021Difficult to Insert; Difficult to Insert
ADDITIONAL INFORMATION RECEIVED, STATES THAT THE COMPONENT DIDN¿T LOCK INTO THE CUP. AND THE RING WAS OKAY. AND SURGERY'S TIME WASN¿T EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11732086 ↗InjuryJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION RIGHT TOTAL HIP REPLACEMENT. PATIENT HAD A REVISION SURGERY ON THE (B)(6) 2020 TO REPLACE A LIPPED DURALOC LINER WITH A CONSTRAINED DURALOC LINER DUE TO DISLOCATION. PATIENT HAS SUBSEQUENTLY DISLOCATED FROM THE CONSTRAINED LINER. SURGEON DECIDED TO REMOVE DURALOC SIZE 54 CUP, ID28 OD54 CONSTRAINED LINER AND 9-10TAPER SIZE 28 ELITE HEAD AND REPLACE IT WITH SIZE 56 PINNACLE MULTIHOLE CUP, ID32 OD 56 PINNACLE CONSTRAINED LINER AND A SIZE 32 9-10 TAPER HEAD. ACCORDING TO THE SURGEON THE PATIENT SLIPPED AND DISLOCATED HER HIP.
Patient problems: Fall; Joint Dislocation; No Code Available
MAUDE report 10344142 ↗InjuryMar 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
DER STATES THAT THE PATIENT CAME TO ER WITH DISLOCATED HIP. LINER WAS REMOVED AND REPLACED. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7352861 ↗
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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