MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE(R) PRESSFIT KEEL; KNEE COMPONENT

Catalog Number KSPP-1512

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-02054, -02055, -02056, -02057.

Event Description

Allegedly, patient revised due to ap instability.

Manufacturer Narrative

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

• Brand Name: ADVANCE(R) PRESSFIT KEEL
• 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: 5313622
• MDR Text Key: 33972452
• Report Number: 3010536692-2015-02058
• Device Sequence Number: 1
• Product Code: MBH
• 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

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: KSPP-1512
• Device Lot Number: 1472994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/08/2015
• Event Location: Hospital
• Date Manufacturer Received: 02/04/2016
• 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: 64 YR