DURALOC 1241-16-527Recalls & reported problems
Depuy Orthopaedics, Inc. · DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 28mm ID 56/68mm OD · Class 2 · Implant
All models of DURALOC (93)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295018735), received between Mar 20, 2018 and Nov 7, 2024 — classified as 4 injuries.
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
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
- Disassembly1
Patient problems
- Insufficient Information2
- Joint Dislocation2
- Fall1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? -> NO. B. PLEASE PROVIDE THE REVISION SURGERY DATE IF AVAILABLE. -> OUTSTANDING AS PE INLAY WAS NOT MANUFACTURED YET.
Patient problems: Insufficient Information
MAUDE report 20632579 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED. SURGEON DECIDED TO INCREASE DURALOC CUP POLY SIZE FROM A 28 TO 36. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 20559263 ↗InjuryJul 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISASSOCIATION OF LOCKING RING. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 14944454 ↗InjuryMar 20, 2018Disassembly; Device Dislodged or Dislocated; Naturally Worn; Disassembly; Device Dislodged or Dislocated; Naturally Worn
DER STATES PATIENT HAS HAD A CONSTRAINED LINER IN FOR APPROXIMATELY 14 YEARS AND WAS SHOWING SIGNS OF WEAR. SURGEON NOTED HOW OVERLY ACTIVE PATIENT WAS INCLUDING PLAYING ON A TRAMPOLINE. CONSTRAINED LOCKING RING WAS DISASSOCIATED FROM POLY AND THERE WAS BLACK TISSUE SURROUNDING IMPLANTS. SHE HAD NOT DISLOCATED IN SEVERAL MONTHS BUT SHE FELT INSTABILITY DURING AMBULATION. DOI: (B)(6) 2003; DOR: (B)(6) 2018; UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 7352224 ↗
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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