Miller™ 5069-52Recalls & reported problems
Zimmer, Inc. · Class 1
Quick summary
This Zimmer Miller 5069-52 is a suction device for surgical cement mixing. The 36 reports mostly describe packaging and sterility problems — damaged boxes, debris or foreign matter found inside the sterile packaging, and product arriving contaminated or unsterile. None involve a patient, and there are no deaths or injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00889024376670), received between Jun 2, 2020 and Oct 22, 2025 — classified as 36 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem15
- Device Contaminated During Manufacture or Shipping12
- Manufacturing, Packaging or Shipping Problem6
- Delivered as Unsterile Product3
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Patient Involvement6
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 25 most recent of 36 reports, 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 ↗MalfunctionAug 10, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT DURING INCOMING INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497850 ↗MalfunctionApr 18, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT INCOMING INSPECTION TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16762994 ↗MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE DISTRIBUTORSHIP FOUND THE PRODUCTS TO BE NONCONFORMING. THEIR INCOMING INSPECTION TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15996852 ↗MalfunctionNov 4, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED DURING THE INCOMING INSPECTION THAT DEBRIS WAS FOUND IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15735411 ↗MalfunctionJul 19, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED UPON INSPECTION IN THE JAPAN WAREHOUSE, TEAM MEMBER FOUND DEBRIS IN STERILE PACKAGE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15053702 ↗MalfunctionJul 19, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED UPON INSPECTION IN THE JAPAN WAREHOUSE, TEAM MEMBER FOUND DEBRIS IN STERILE PACKAGE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15053673 ↗MalfunctionJul 1, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE DISTRIBUTION WAREHOUSE FOUND DEBRIS IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14885046 ↗MalfunctionMay 5, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS DEBRIS IN THE STERILE PACKAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14291815 ↗MalfunctionMay 5, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS DEBRIS IN THE STERILE PACKAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14291798 ↗MalfunctionApr 28, 2021Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11738027 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.