• 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. ADVANCEPRESS FIT KEEL PRIMARY 15MM X SIZE 1/1+/2; 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. ADVANCEPRESS FIT KEEL PRIMARY 15MM X SIZE 1/1+/2; KNEE COMPONENT Back to Search Results
Model Number KSPP1512
Device Problem Loss of Osseointegration (2408)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event 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
ADVANCEPRESS FIT KEEL PRIMARY 15MM X SIZE 1/1+/2
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 Key9873242
MDR Text Key186556462
Report Number3010536692-2020-00277
Device Sequence Number1
Product Code MBH
UDI-Device IdentifierM684KSPP15121
UDI-PublicM684KSPP15121
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061223
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 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
Device Operator Other
Device Model NumberKSPP1512
Device Catalogue NumberKSPP1512
Device Lot Number1680730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/26/2020
Initial Date Manufacturer Received 02/26/2020
Initial Date FDA Received03/24/2020
Supplement Dates Manufacturer Received02/26/2020
Supplement Dates FDA Received10/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
-
-