MAUDE Adverse Event Report: STRYKER SIMPLEX BONE CEMENT

Model Number 61979001

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 03/11/2021

Event Type  Injury  

Event Description

Clinical adverse event received for worsened chronic patellar subluxation.Event is not serious and is considered moderate.Event is definitely not related to device and is definitely related to procedure.(right knee) original implant date (b)(6) 2019.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIMPLEX BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17528943
• MDR Text Key: 321136724
• Report Number: MW5135872
• 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: 03/25/2021

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 Model Number: 61979001
• Device Lot Number: MKZ073
• Patient Sequence Number: 1