• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 6 STANDARD 10MM RIGH; KNEE COMPONENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 6 STANDARD 10MM RIGH; KNEE COMPONENT Back to Search Results
Model Number EIS6S10R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, patient underwent right tkr on (b)(6) 2017.Revised on (b)(6) 2021 due to infection.10mm insert replaced with the same size.(b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVOLUTION MP CS INSERT SIZE 6 STANDARD 10MM RIGH
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 Key11565564
MDR Text Key242164280
Report Number3010536692-2021-00162
Device Sequence Number1
Product Code HRY
UDI-Device IdentifierM684EIS6S10R1
UDI-PublicM684EIS6S10R1
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K093552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2021
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 Model NumberEIS6S10R
Device Catalogue NumberEIS6S10R
Device Lot Number1720935
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/28/2021
Initial Date Manufacturer Received 02/28/2021
Initial Date FDA Received03/24/2021
Supplement Dates Manufacturer Received02/28/2021
Supplement Dates FDA Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-