MAUDE Adverse Event Report: STRYKER CORPORATION BIOPREP; PROSTHESIS, HIP, CEMENT RESTRICTOR

Model Number 0206710000

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/30/2021

Event Type  malfunction  

Event Description

Cement restrictor from the bioprep bone preparation system broke during patient's procedure.Anatomically, canal was noted as narrow where the cement restrictor was placed.The inserter handle became stuck in canal.The plastic inserter had to be cut and ream the canal free.Increased length of time for procedure.The patient developed post operatively arterial occlusion requiring vascular consult/intervention.

• Brand Name: BIOPREP
• Type of Device: PROSTHESIS, HIP, CEMENT RESTRICTOR
• Manufacturer (Section D): STRYKER CORPORATION; 325 corporate dr.; mahwah NJ 07430
• MDR Report Key: 11982737
• MDR Text Key: 255657645
• Report Number: 11982737
• Device Sequence Number: 1
• Product Code: JDK
• 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: 06/02/2021,06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0206710000
• Device Catalogue Number: 0206-710-000
• Device Lot Number: 21060012
• 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: 06/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28835 DA
• Patient Weight: 47