MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP SIMPLEX CEMENT; BONE CEMENT

Catalog Number 61911001

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Paresthesia (4421)

Event Date 01/24/2023

Event Type  Injury  

Event Description

Clinical adverse event received for pins and needles l knee and limited rom.Event is not serious and is considered mild.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2022.Date of event: (b)(6) 2023.(left knee) (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIMPLEX CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP
• MDR Report Key: 17488386
• MDR Text Key: 320681455
• Report Number: MW5121085
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 61911001
• Device Lot Number: RDD051
• Patient Sequence Number: 1