MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. BUCK FEMORAL CEMENT RESTRICTOR 25MM; CEMENT OBTURATOR

Catalog Number 129419

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Clinical adverse event received for general knee pain.Left knee original implant date (b)(6) 2021.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BUCK FEMORAL CEMENT RESTRICTOR 25MM
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): SMITH AND NEPHEW, INC.
• MDR Report Key: 17537147
• MDR Text Key: 321316265
• Report Number: MW5144027
• Device Sequence Number: 1
• Product Code: LZN
• 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: 02/14/2022

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: 129419
• Device Lot Number: 21ESM0013 , 21DSM012
• Patient Sequence Number: 1