Miller™ 5069-54Recalls & reported problems
Zimmer, Inc. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024376687), received between Dec 19, 2022 and Dec 19, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2022Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY THE INCOMING INSPECTION TEAM WITH OUR DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. THEIR INCOMING INSPECTION TEAM MEMBER FOUND HAIR LIKE DEBRIS IN THE STERILE PACKAGING. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16006204 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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