MAUDE Adverse Event Report: STRYKER BONE CEMENT

Catalog Number 61969001, LOT: 3150630BAV0038S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Procedure: tka.Using: ps fb.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17528359
• MDR Text Key: 321413785
• Report Number: MW5135290
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 61969001, LOT: 3150630BAV0038S
• Patient Sequence Number: 1