MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN(R) TIBIAL HINGE BASE; KNEE COMPONENT

Model Number 2500-2100

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/01/2017

Event Type  Injury  

Event Description

According to the notification, event happened at (b)(6).A patient was performed a surgical operation for tumor resection due to right tibial proximal's diagnosis of osteosarcoma in 2014.During medical examination in 2017, the doctor has suspected that the hinge on the joint of product (guardian tibial hinge base w/ rotational stop pin) might be fractured and also the patient has to undergo a surgical operation again.

• Brand Name: GUARDIAN(R) TIBIAL HINGE BASE
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 7274216
• MDR Text Key: 100188640
• Report Number: 3010536692-2018-00131
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 2500-2100
• Device Catalogue Number: 2500-2100
• Device Lot Number: 1508391
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/01/2018
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention