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

Model Number 2500-2101

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trend will be evaluated.

Event Description

Allegedly onkos received an explanted components from a revision surgery.The reason for the revision surgery is unknown, but the tibial hinge component's stem was fractured.

• Brand Name: GUARDIAN(R) TIBIAL HINGE BASE
• Type of Device: HIP 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: 7851476
• MDR Text Key: 119388217
• Report Number: 3010536692-2018-01157
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2500-2101
• Device Catalogue Number: 2500-2101
• Device Lot Number: 1658829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 12/28/2018
• 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
• Patient Age: 29 YR