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. ADVANCE PRIMARY FEMORAL SIZE 4 LEFT POROUS; 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. ADVANCE PRIMARY FEMORAL SIZE 4 LEFT POROUS; KNEE COMPONENT Back to Search Results
Model Number KFTCPC4L
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
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, looks like the tibial base plate is loosening , patella was spinning and femur could not balance in flexion and extension so femur had to go additional information: left knee.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADVANCE PRIMARY FEMORAL SIZE 4 LEFT POROUS
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9844659
Report Number3010536692-2020-00244
Device Sequence Number19547063
Product Code MBH
UDI-Device IdentifierM684KFTCPC4L1
UDI-PublicM684KFTCPC4L1
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K061223
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/02/2020
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 NumberKFTCPC4L
Device Catalogue NumberKFTCPC4L
Device Lot Number1696540
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/26/2020
Initial Date Received by Manufacturer 02/26/2020
Supplement Date Received by Manufacturer02/26/2020
Initial Report FDA Received Date03/17/2020
Supplement Report FDA Received Date10/02/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
-
-