MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4+ 12MM RIGHT; KNEE COMPONENT

Model Number EIS4P12R

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly the knee had loosened up.Had a lot of varus/valgus laxity and hyper-extension.Took out a 12mm insert and replaced it with a 17mm insert.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4+ 12MM RIGHT
• 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: 8679983
• MDR Text Key: 147365654
• Report Number: 3010536692-2019-00816
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS4P12R1
• UDI-Public: M684EIS4P12R1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS4P12R
• Device Catalogue Number: EIS4P12R
• Device Lot Number: 1677981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2019
• Date Manufacturer Received: 05/29/2019
• 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: 74 YR