MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE; UNICONDYLAR KNEE IMPLANT

Model Number STRIDE FEMORAL COMPONENT

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 05/27/2014

Event Type  Other  

Event Description

The surgeon prepared femur for a size 2, right medial.When asked for implant components, the implants were reviewed with scrub tech prior to opening sterile pouch.The actual femur implant was for a left medial.The product may be mislabeled and could result in the incorrect implant being used.

• Brand Name: STRIDE
• Type of Device: UNICONDYLAR KNEE IMPLANT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; plymouth 55441
• MDR Report Key: 3883925
• MDR Text Key: 4591142
• Report Number: MW5036669
• Device Sequence Number: 1
• Product Code: HSX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: STRIDE FEMORAL COMPONENT
• Device Catalogue Number: PFSI-00053
• Device Lot Number: C785231
• Other Device ID Number: NONE
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other