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

Model Number 2500-1208

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to aseptic loosening femur; aseptic loosening tibia, lysis femur; lysis tibia (right).

• Brand Name: GUARDIAN(R) TIBIAL SLEEVE SPACER
• 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: 7809519
• MDR Text Key: 118010249
• Report Number: 3010536692-2018-01089
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 08/23/2018

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: 2500-1208
• Device Catalogue Number: 2500-1208
• Device Lot Number: 1529177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2018
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 12/14/2018
• 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