DURALOC 1242-14-527Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 32mm 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
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295019176), received between Jul 13, 2018 and Feb 18, 2025 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Adverse Event Without Identified Device or Use Problem2
- Fracture1
- Material Deformation1
Patient problems
- Joint Dislocation4
- No Code Available3
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT ID: (B)(4). STUDY NO: DOTS CLINICAL ADVERSE EVENTS RECEIVED FOR DISLOCATION - REOCCURRENCE DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY PROCEDURE RELATED: PROBABLY DATE OF EVENT: 15/NOV/2024 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: NO INFORMATION PROVIDED DEPUY SYNTHES PRODUCT USED: CATALOG ID: 124603000 LOT ID: U55HM1000 COMPONENT TYPE: ACC DESCRIPTION: APEX HOLE ELIM POSITIVE STOP. CATALOG ID: 124754000 LOT ID: UC8A41024 COMPONENT TYPE: SHELL DESCRIPTION: DURALOC SHELL 100 SERIES 54MM CATALOG ID: 521423 LOT ID: 642458 COMPONENT TYPE: SLEEVE DESCRIPTION: SROM SLEEVE PROX ZTT 22B SM CATALOG ID: 523422 LOT ID: 822029 COMPONENT TYPE: STEM DESCRIPTION: SROM STEM STD 36MM +8L NECK 22MM X 17MM X165MM. CATALOG ID: 124954000 LOT ID: M6081K COMPONENT TYPE: RING DESCRIPTION: DURALOC DYNAMIC LOCK RING 54MM CATALOG ID: 875956 LOT ID: 3770845 COMPONENT TYPE: HEAD DESCRIPTION: SROM HEAD 32MM + 9MM CATALOG ID: 124954000 LOT ID: M5355C COMPONENT TYPE: RING DESCRIPTION: DURALOC DYNAMIC LOCK RING 54MM CATALOG ID: 124214527 LOT ID: M2068Y COMPONENT TYPE: LINER DESCRIPTION: DURALOC LINER CONSTRAINE
Patient problems: Joint Dislocation
MAUDE report 21403112 ↗InjurySep 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 17842708 ↗InjuryMar 29, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS PATIENT DISLOCATION AND THAT THE LINER WAS EXCHANGED BECAUSE IT BROKE. DOI: UNKNOWN. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 11582752 ↗InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CUP REMOVED WAS A DEPUY PRODUCT (DURALOC 300) AND WAS REPLACED WITH A BIOMET CUP.
Patient problems: No Code Available
MAUDE report 10198175 ↗InjuryMar 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURGEON REVISED A DURALOC CONSTRAINED LINER THAT HAD DISLOCATED. THE LINER AND HEAD WERE REMOVED AND NEW IMPLANTS USED. THERE WAS NO NOTED DEFICIENCY WITH THE EXPLANTED ITEMS. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 9904329 ↗InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionJul 13, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SURGEON PUT IN A CONSTRAINED LINER AND DID NOT FULLY ENGAGE INTO HEAD. WENT TO PUT IN CONSTRAINED LINER RING AND THE HEAD POPPED OUT BECAUSE ITS NOT FULLY ENGAGED. EXTRACTED LINER AND TRIED TO REMOVE LINER RING. IT WOULD NOT COME OUT SO THEY SWITCHED TO A REGULAR DURALOC LINER 10 DEGREE. DOE: (B)(6) 2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7685091 ↗
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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