MAUDE Adverse Event Report: CARDINAL HEALTH/CARDINAL HEALTH 200, LLC CENTENNIAL TOTAL KNEE PK; ORTHOPEDIC TRAY

Catalog Number SOP73KTCTH

Device Problem Contamination (1120)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Hair found in pack.Fda safety report id # (b)(4).

• Brand Name: CENTENNIAL TOTAL KNEE PK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH/CARDINAL HEALTH 200, LLC; waukegan IL 60085
• MDR Report Key: 14111717
• MDR Text Key: 289349514
• Report Number: MW5108985
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• 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
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SOP73KTCTH
• Device Lot Number: 752036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1