MAUDE Adverse Event Report: ZIMMER/BIOMET, INC. ZIMMER BIOMET TRIAL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 42-5274-010-10

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

Cracked trial found in a zimmer loaner pan during assembly.Vendor: zimmer/biomet.Item# 42-5274-010-10 (size 10-12/g-h) vendors must do a better job with checking their instrumentation for functionality and cleanliness before bringing them into the facility.Zimmer/biomet.Zimmer rep location: madison wi.

• Brand Name: ZIMMER BIOMET TRIAL
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ZIMMER/BIOMET, INC.
• MDR Report Key: 16529568
• MDR Text Key: 311220216
• Report Number: MW5115673
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-5274-010-10
• Device Catalogue Number: 42-5274-010-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1