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 II MEDIAL PIVOT TIBIAL INSERT SZ 1 LEFT 1; 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 II MEDIAL PIVOT TIBIAL INSERT SZ 1 LEFT 1; KNEE COMPONENT Back to Search Results
Model Number KIMP110L
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 l tkr on (b)(6) 2016.Revised by another surgeon on (b)(6) 2021 due to ligament laxity.Patella resurfaced and insert replaced from 10mm to 14mm thickness.(b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 1 LEFT 1
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11568179
Report Number3010536692-2021-00163
Device Sequence Number3459748
Product Code JWH
UDI-Device IdentifierM684KIMP110L1
UDI-PublicM684KIMP110L1
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
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) 05/19/2021
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 NumberKIMP110L
Device Catalogue NumberKIMP110L
Device Lot Number0863628201591826
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/01/2021
Initial Date Received by Manufacturer 03/01/2021
Supplement Date Received by Manufacturer03/01/2021
Initial Report FDA Received Date03/25/2021
Supplement Report FDA Received Date05/19/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
-
-