DURALOCRecalls & reported problems across all models
Depuy (Ireland) · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 341
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 23 models of DURALOC by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 341 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Jun 18, 2026 — classified as 25 injuries, 316 malfunctions.
The most frequently reported specific device problem is “Break” (130 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DURALOC problems
Device problems
- Break130
- Crack101
- Device-Device Incompatibility55
- Naturally Worn21
- Adverse Event Without Identified Device or Use Problem16
- Appropriate Device Problem Term/Code Not Available16
- Mechanical Jam14
- Material Deformation13
Patient problems
- No Consequences Or Impact To Patient166
- No Clinical Signs, Symptoms or Conditions116
- No Information35
- Insufficient Information17
- No Code Available15
- Pain9
- Joint Laxity4
- Not Applicable4
DURALOC models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DURALOC 2244-08-000IMPACTOR267 reports
- DURALOC 2015-24-000IMPACTOR14 reports
- DURALOC 1245-80-049Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- DURALOC 2274-09-000BIT, DRILL6 reports
- DURALOC 1245-80-054PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- DURALOC 1245-80-055PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- DURALOC 1245-80-056Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- DURALOC 2237-50-000TEMPLATE5 reports
- DURALOC 1245-80-051PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- DURALOC 2244-14-000EXTRACTOR4 reports
- DURALOC 1245-80-052PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- DURALOC 1245-80-050PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- DURALOC 2238-18-000TEMPLATE2 reports
- DURALOC 2247-12-000TEMPLATE2 reports
- DURALOC 2247-14-000TEMPLATE2 reports
- DURALOC 2247-18-000TEMPLATE2 reports
- DURALOC 1245-80-053Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- DURALOC 2237-08-000TEMPLATE1 report
- DURALOC 2237-10-000TEMPLATE1 report
- DURALOC 2237-18-000TEMPLATE1 report
- DURALOC 2238-20-000TEMPLATE1 report
- DURALOC 2238-26-000TEMPLATE1 report
- DURALOC 2238-52-000TEMPLATE1 report
Recent DURALOC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Mechanical Jam
IT WAS REPORTED THAT THE MECHANISM IS JAMMING AND THE HANDLE CAN¿T BE USED ANYMORE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553456 ↗MalfunctionJun 12, 2026Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE WAS GETTING STUCK IN THE STAR DRIVER CUP INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484416 ↗MalfunctionMay 14, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE THREADS OF THE IMPACTOR HANDLE WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175258 ↗MalfunctionMay 14, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE THREADS OF THE IMPACTOR HANDLE WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175251 ↗MalfunctionMay 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS LOOSE CONNECTION. THE INSERTER FELL OFF THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163654 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED THAT DURALOC CUP IMPACTOR HANDLE SHATTERED DURING TRIAL IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031453 ↗MalfunctionApr 13, 2026Device-Device Incompatibility
IT WAS REPORTED THAT PEGS ON DURALOC CURVED CUP IMPACTOR NO LONGER FIT WITH TIP OF THE IMPACTOR AND 54 36 NEUTRAL TRIAL LINER. INNER SCREW MECHANISM WAS STRIPPED THERE WERE NO BROKEN PIECES AND NO DELAYS OR COMPLICATIONS TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859533 ↗MalfunctionApr 2, 2026Break; Crack
IT WAS REPORTED THAT THE HANDLE IS CRACKED /BROKEN. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766913 ↗MalfunctionMar 31, 2026Break; Device-Device Incompatibility
THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE TRYING TO USE 2X DURALOC CURVED CUP IMPACTOR DEVICES, THE END PIECES WERE VERY HARD TO REMOVE ONCE SNAPPED ONTO THE INSERTER AND EVEN BECAME STUCK ON. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746577 ↗MalfunctionMar 31, 2026Break; Device-Device Incompatibility
THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE TRYING TO USING 2X DURALOC CURVED CUP IMPACTOR DEVICES THE END PIECES WERE VERY HARD TO REMOVE ONCE SNAPPED ONTO THE INSERTER AND EVEN BECAME STUCK ON. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746567 ↗MalfunctionMar 25, 2026Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BUTTONS WERE LOOSE ON THE HANDLES. IT WAS REPORTED THAT THE DEVICE WOULD NOT CONNECT TO THE ATTACHMENT PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690904 ↗MalfunctionMar 25, 2026Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BUTTONS WERE LOOSE ON THE HANDLES. IT WAS REPORTED THAT THE DEVICE WOULD NOT CONNECT TO THE ATTACHMENT PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690902 ↗MalfunctionMar 25, 2026Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BUTTONS WERE LOOSE ON THE HANDLES. IT WAS REPORTED THAT THE DEVICE WOULD NOT CONNECT TO THE ATTACHMENT PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690872 ↗MalfunctionFeb 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY TWO REMOVABLE TIPS ON THE DURALOC CURVED CUP IMPACTORS BECAME STUCK ONTO THEIR HANDLES. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. ACTIVITY LEVEL - YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293101 ↗MalfunctionFeb 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY TWO REMOVABLE TIPS ON THE DURALOC CURVED CUP IMPACTORS BECAME STUCK ONTO THEIR HANDLES. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. ACTIVITY LEVEL - YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293098 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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