DURALOC 1242-18-527Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 32mm ID 58/70mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295019237), received between Dec 19, 2017 and Aug 7, 2025 — classified as 6 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem2
- Naturally Worn1
Patient problems
- Joint Dislocation3
- No Code Available2
- Unspecified Infection2
- Insufficient Information1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR CERAMIC HEAD AND POLY LINER EXCHANGE BECAUSE OF INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 22744405 ↗InjuryJun 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A DURALOC CONSTRAINED LINER DISSOCIATED FROM THE CUP RESULTING IN A REVISION SURGERY BEING REQUIRED TO REMOVE THE HEAD AND A LINER AND INSERT NEW COMPONENTS. THIS WAS IN A TOTAL HIP REPLACEMENT FOLLOWING THE LINER BEING IN FOR APPROXIMATELY 1 YEAR. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 14644527 ↗InjuryDec 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT ACCORDING TO DR. (B)(6) THIS PATIENT CAME INTO THE ER AT (B)(6) WITH A DISLOCATED HIP. THE SURGEON TOLD ME THAT DR. (B)(6) HAD REVISED THIS PATIENTS HIP ON (B)(6) 2009 AT (B)(6) FOR INSTABILITY. THE X-RAYS DR. (B)(6) SHARED WITH ME REVEALED THAT IT WAS A DURALOC ACETABULAR CUP WITH WHAT APPEARED TO BE A AML STEM. DR. (B)(6) EXPLANTED THE DURALOC CONSTRAINED LINER AND A TS CERAMIC 28MM HIP BALL. A NEW ACETABULAR CUP, LINER, AND HIP BALL WAS IMPLANTED. THE STEM WAS LEFT IN SITU. DOI: (B)(6) 2009. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 12960313 ↗InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS HAD NUMEROUS SURGERIES, NUMEROUS REVISIONS. THE PATIENT HAS A CHRONIC INFECTION, AND THE CABLES ON THE FEMUR ARE CAUSING HIM PAIN. THE SURGEON DID NONE OF THE SURGERIES, BUT HE IS REMOVING THE CABLES, WASHING OUT AND CHANGING THE HEAD AND CONSTRAINED LINER. DOI: UNKNOWN, DOR: (B)(6) 202, AFFECTED SIDE: UNKNOWN.
Patient problems: No Code Available; Pain; Unspecified Infection
MAUDE report 10173904 ↗InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED TO ADDRESS FREQUENT DISLOCATION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8069157 ↗InjuryDec 19, 2017Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AFTER 13-15 YEARS OF SUCCESSFUL SURGERY. IT WAS STATED THAT THERE WAS SOME ECCENTRIC POLYWEAR. DOI: 1998 DOR: (B)(6) 2017 RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 7128247 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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