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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER BIOMET VARIOUS KITS CONTAINING ACDA

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ZIMMER BIOMET ZIMMER BIOMET VARIOUS KITS CONTAINING ACDA Back to Search Results
Catalog Number 800-1003A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Other  
Event Description
Infection in surgical site.
 
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Brand Name
ZIMMER BIOMET VARIOUS KITS CONTAINING ACDA
Type of Device
ZIMMER BIOMET VARIOUS KITS CONTAINING ACDA
Manufacturer (Section D)
ZIMMER BIOMET
po box 587
MDR Report Key5829656
MDR Text Key51240263
Report NumberMW5063688
Device Sequence Number1
Product Code KSS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number800-1003A
Device Lot Number402274
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/25/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age58 YR
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