MAUDE Adverse Event Report: OSARTIS GMBH SIMPLEX HV; BONE CEMENT

Catalog Number 6194-1-001

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

Dr.Was doing a total knee arthroplasty case.He initially used 2 batches of stryker simplex hv cement.Both batches of cement had the same lot number.The surgical tech mixed the cement for 30 seconds (manufacturers recommendation) and the cement set up too quickly.Dr.Then ended up having to use an additional batch of simplex speedset cement to finish the case.A representative of stryker was present for the case during the cementing portion.

• Brand Name: SIMPLEX HV
• Type of Device: BONE CEMENT
• Manufacturer (Section D): OSARTIS GMBH; 7 trail house court; rockville MD 20850
• MDR Report Key: 12638604
• MDR Text Key: 276589010
• Report Number: 12638604
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6194-1-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 98