MAUDE Adverse Event Report: STRYKER INC. CEMENT SIMPLEX ANTIBIOTIC BONE; BONE CEMENT, ANTIBIOTIC

Model Number 61969001

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

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 09/18/2020

Event Type  Injury  

Event Description

Clinical adverse event received for pain and swelling.Event is not serious and is considered mild.Event is not related to device and is possibly related to procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CEMENT SIMPLEX ANTIBIOTIC BONE
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER INC.
• MDR Report Key: 17531279
• MDR Text Key: 321049654
• Report Number: MW5138194
• Device Sequence Number: 1
• Product Code: MBB
• 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 Model Number: 61969001
• Device Lot Number: BHV0278
• Patient Sequence Number: 1