RECLAIM 44-00000-32Recalls & reported problems
Depuy (Ireland) · RECLAIM MONOBLOC REVISION HIP SYSTEM REAMER EXTENSION · Class 1
All models of RECLAIM (149)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295537250), received between Jan 2, 2024 and Aug 6, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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-Device Incompatibility2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THAT THE SURGEON USED A MALLET AND BROKE THE REAMER GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726925 ↗MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SHAFT WOULD NOT CONNECT TO ANY OF THE HUDSONS. THIS DID NOT SLOW DOWN THE CASE BECAUSE THEY HAD A BACKUP READY TO GO. THE CASE PROCEEDED AS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370054 ↗MalfunctionJan 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMER EXTENSION WON'T STAY LOCKED ON THE REAMER.
Patient problems: Insufficient Information
MAUDE report 18429956 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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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