MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION(TM) MP CS INSERT; KNEE

Catalog Number EIS4-S10L

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly in the process of trying to engage the locking mechanism in routine fashion with two 10mm thick tibial inserts, were unable to get the locking mechanism to seat fully circumferential.Also had trouble getting the posterior flange of the tibial base plate fully seated inferiorly and the medial side.Additional information: 10 mm polys would not lock into tibial base plate through the doctors normal method used to lock in polys.Dr (b)(6) has had other polys this year that failed to properly engage into the tib base.These poly's locking mech were impacted to a point that they were deemed as "wasted".Dr.(b)(6) stated that there must be something wrong with the polys or the tib base.

• Brand Name: EVOLUTION(TM) MP CS INSERT
• Type of Device: KNEE
• 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: 6173610
• MDR Text Key: 62350346
• Report Number: 3010536692-2016-01519
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

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: EIS4-S10L
• Device Lot Number: 15448041552011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/01/2016
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• 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