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

Catalog Number KTCC-NP20

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Neck Stiffness (2434)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revised due to aseptic loosening femur; aseptic loosening tibia; mal-alignment; stiffness; wear of polyethylene component.(right) age at primary: (b)(6).Primary asa: p2-mild disease not incapacitating.Revision njr index no: (b)(4).

Manufacturer Narrative

Upon reassessment of the reported event we have determined that this is a duplicate that was previously reported under (b)(4).

• Brand Name: ADVANCE(R) II TIBIAL 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: 6110283
• MDR Text Key: 60248042
• Report Number: 3010536692-2016-01413
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K960617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: KTCC-NP20
• Device Lot Number: 55229097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/24/2016
• Date Manufacturer Received: 10/24/2016
• 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