Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 5 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 5 STANDARD 10MM RIGH; KNEE COMPONENT Back to Search Results
Model Number EIS5S10R
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient underwent r tkr on (b)(6) 2015.Revised on (b)(6) 2021 due to pain.Surgeon resurfaced the patella and revised liner from 10mm to 14mm.(b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVOLUTION MP CS INSERT SIZE 5 STANDARD 10MM RIGH
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12360206
Report Number3010536692-2021-00448
Device Sequence Number4739079
Product Code HRY
UDI-Device IdentifierM684EIS5S10R1
UDI-PublicM684EIS5S10R1
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/20/2021
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
Operator of Device Other
Device Model NumberEIS5S10R
Device Catalogue NumberEIS5S10R
Device Lot Number15616711579315
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/08/2021
Initial Date Received by Manufacturer 08/08/2021
Supplement Date Received by Manufacturer08/08/2021
Initial Report FDA Received Date08/24/2021
Supplement Report FDA Received Date10/20/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age81 YR
-
-