ENDURANCE 2521-00-502Recalls & reported problems
Depuy Orthopaedics, Inc. · ENDURANCE STEM INSERTER · Class 1
All models of ENDURANCE (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295127796), received between Oct 23, 2018 and May 4, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 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
- Material Deformation3
- Break1
- Entrapment of Device1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Not Applicable1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Material Deformation
IT WAS REPORTED THAT THE DAMAGED TIP OF INSERTER WITH TRAYS WAS BEING STACKED ON IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25067739 ↗MalfunctionApr 9, 2026Material Deformation
IT WAS REPORTED THAT INSERTER TIP FOR ENDURANCE WAS BENT. STRAIGHT REAMER SHAFT WAS WOBBLING. LPS STEM INSERTER WAS BROKEN. THE 45 DEGREE ANGLE DRILL WAS BROKEN. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829895 ↗MalfunctionAug 10, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIP IS BENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300346 ↗MalfunctionJul 16, 2020Break; Break
THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING THE IMPLANTING THE STEM, WHEN THE SURGEON IMPACTED A STEM WITH THE INSERTER (P/N: 252100502), THE TIP OF INSERTER¿S THIN PART BROKE. AFTER THAT, THE SURGEON IMPACTED THE STEM WITH ANOTHER DEVICE. AND, WHEN INSERTING A CUP, THE PLASTIC PART OF THE INSERTER (P/N: 920010029) BROKE. BECAUSE THE LAST TIMING OF IMPACTING OF A CUP, THE SURGEON DETACHED THE INSERTER. THE SURGEON CHECKED THE BODY THOROUGHLY AND CONFIRMED NO FRAGMENT OF BOTH DEVICES IN THE BODY. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10281287 ↗MalfunctionMay 18, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TIP IS DAMAGED AND CAN¿T BE USED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10065896 ↗InjuryOct 23, 2018Entrapment of Device; Entrapment of Device
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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