MillerRecalls & reported problems across all models
Zimmer, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Miller by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2020 and Oct 22, 2025 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (15 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 Miller problems
Device problems
- Packaging Problem15
- Device Contaminated During Manufacture or Shipping13
- Manufacturing, Packaging or Shipping Problem7
- Delivered as Unsterile Product3
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Patient Involvement6
- No Known Impact Or Consequence To Patient2
- No Information1
Miller models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Miller™ 5069-52EVACUATOR, VAPOR, CEMENT MONOMER36 reports
- Miller™ 5069-54DISPENSER, CEMENT1 report
Recent Miller adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THERE IS NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358195 ↗MalfunctionOct 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THERE IS NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358193 ↗MalfunctionJun 27, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344252 ↗MalfunctionJun 26, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338277 ↗MalfunctionFeb 5, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE PRODUCT WAS NOTED TO HAVE A FOREIGN SUBSTANCE IN THE STERILE PACKAGING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313112 ↗MalfunctionJan 24, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21228317 ↗MalfunctionJul 12, 2024Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19729558 ↗MalfunctionMay 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE PRODUCTS WERE RECEIVED BY THE DISTRIBUTOR, THEY WERE FOUND TO HAVE DAMAGED PACKAGING. THE OUTER CAVITY WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19261328 ↗MalfunctionMay 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHEN THE PRODUCTS WERE RECEIVED BY THE DISTRIBUTOR, THEY WERE FOUND TO HAVE DAMAGED PACKAGING. BOTH THE OUTER AND INNER CAVITIES WERE FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19261326 ↗MalfunctionDec 21, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INSPECTION OF STOCK, DEBRIS WAS FOUND IN THE PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371334 ↗MalfunctionSep 25, 2023Packaging Problem; Packaging Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17812950 ↗MalfunctionSep 20, 2023Packaging Problem; Packaging Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17784440 ↗MalfunctionSep 18, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17764118 ↗MalfunctionAug 21, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17585558 ↗MalfunctionAug 21, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT AN INCOMING INSPECTION TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17585547 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
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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