MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCED TIBIAL BASE SZ3; KNEE COMPONENT

Catalog Number KTCC-NP3X

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

This report will be update investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the patient was revised due to loose tibial base.

• Brand Name: ADVANCED TIBIAL BASE SZ3
• 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: 5323183
• MDR Text Key: 34239924
• Report Number: 3010536692-2015-02060
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

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 Catalogue Number: KTCC-NP3X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/04/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• 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: 76 YR