DURALOC 1242-12-527Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 32mm ID 52mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295019145), received between Oct 13, 2017 and Aug 28, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 Dislocated9
- Disassembly1
Patient problems
- Joint Dislocation9
- No Code Available3
- Discomfort1
- Fall1
- Joint Disorder1
- Pain1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Device Dislodged or Dislocated
It was reported that the patient presented dislocated for a fall. Head and liner exchange was made and patient was stable with proper leg length.DOI: (b)(6) 2023.DOR: (b)(6) 2026.Affected side: Right.
Patient problems: Fall; Joint Dislocation
MAUDE report 50505964 ↗InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE DURALOC LOCKING RING WAS BROKEN. HIP GOT DISLOCATED. DOI: UNK. DOR: (B)(6) 2025. AFFECTED AREA: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 22309467 ↗InjuryNov 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED, THAT THE PATIENT WAS REVISED, DUE TO DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20604527 ↗InjurySep 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATIONS. THE PATIENT TOLD TO SURGEON, THAT HER CURRENT DISLOCATED HIP WAS HER THIRD DISLOCATION. PATIENT'S DEPUY HIP HAD BEEN PREVIOUSLY REVISED ELSEWHERE. DURING THAT PROCEDURE, IT APPEARS THAT, PRIMARY DURALOC LINER WAS REPLACED BY A DURALOC CONSTRAINED LINER, BASED UPON THE PATIENT'S CURRENT COMPONENTS. DURING THIS PARTICULAR DISLOCATION. THE OUTER LOCKING RING OF THE CONSTRAINED LINER HAD BECOME SEPARATED FROM THE LINER AND THE FEMORAL HEAD HAD BECOME DISLOCATED FROM THE LINER. DURING THIS PARTICULAR REVISION PROCEDURE, THE DURALOC CUP, LINER AND LOCKING RING WERE REMOVED AND REPLACED BY A LARGER STRYKER ACETABULAR CUP. THE DEPUY 32MM LARGE TAPER METAL FEMORAL HEAD WAS REPLACED BY A DEPUY 36MM LARGE TAPER METAL FEMORAL HEAD. THE PATIENT'S AML DID NOT NEED TO BE REPLACED. THERE WAS NO LOOSENING. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 15391657 ↗InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATIONS. THE PATIENT TOLD THE DOCTOR THAT HER CURRENT DISLOCATED HIP WAS HER THIRD DISLOCATION. HER DEPUY HIP HAD BEEN PREVIOUSLY REVISED ELSEWHERE. DURING THAT PROCEDURE, IT APPEARS THAT HER PRIMARY DURALOC LINER WAS REPLACED BY A DURALOC CONSTRAINED LINER, BASED UPON HER CURRENT COMPONENTS. DURING THIS PARTICULAR DISLOCATION. THE OUTER LOCKING RING OF THE CONSTRAINED LINER HAD BECOME SEPARATED FROM THE LINER AND THE FEMORAL HEAD HAD BECOME DISLOCATED FROM THE LINER. DURING THIS PARTICULAR REVISION PROCEDURE, THE DURALOC CUP, LINER AND LOCKING RING WERE REMOVED AND REPLACED BY A LARGER STRYKER ACETABULAR CUP. THE DEPUY 32MM LARGE TAPER METAL FEMORAL HEAD WAS REPLACED BY A DEPUY 36MM LARGE TAPER METAL FEMORAL HEAD. THE PATIENT'S AML DID NOT NEED TO BE REPLACED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 15363063 ↗InjuryOct 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED A CONSTRAINED LINER, SO THEY REMOVED THE CUP AND CHANGED POSITION OF THE CUP. DOI: (B)(6) 2020. DOR: (B)(6), 2020. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10684701 ↗InjuryJun 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
RIGHT HIP REVISION - ORIGINAL SURGERY DONE (B)(6) 2017. PATIENT HAD DISLOCATIONS, CONSTRAINED LINER LOCKING RING CAME OFF. REMOVED HEAD, LINER AND HOLE ELIMINATOR. LEFT ORIGINAL HEAD IN.
Patient problems: Joint Dislocation; Joint Disorder; No Code Available
MAUDE report 8686943 ↗InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8315333 ↗InjuryJan 4, 2018Disassembly; Disassembly
IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND POSSIBLE LOOSENING. REVISION NOTES REPORTED THAT THE CONSTRAINING RING CAME OUT AND DISASSOCIATED FROM THE POLYETHYLENE. CLINICAL NOTES REPORTED PAIN AND DISCOMFORT. DOI: (B)(6) 2003; DOR: (B)(6) 2006; RIGHT HIP.
Patient problems: Discomfort; Pain
MAUDE report 7163397 ↗InjuryOct 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. STEM WAS REVISED AND THE VERSION.
Patient problems: Joint Dislocation
MAUDE report 6948984 ↗
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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