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

Catalog Number 800-1003A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Other  

Event Description

Infection in surgical site.

• 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 Key: 5829656
• MDR Text Key: 51240263
• Report Number: MW5063688
• Device Sequence Number: 1
• Product Code: KSS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 800-1003A
• Device Lot Number: 402274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR