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

Catalog Number KTCC-NP10

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/22/2015

Event Type  Injury  

Manufacturer Narrative

The investigation is not complete.The trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 3010536692-2015-01860 and 01862.This event occurred in (b)(6).

Event Description

Allegedly revised due to infection (right).

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

• 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: 5162636
• MDR Text Key: 28800208
• Report Number: 3010536692-2015-01861
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: KTCC-NP10
• Device Lot Number: 078651100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/22/2015
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2015
• 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