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

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MOVATION KNEE MOVATION TIBIAL INSERT, SIZE 8, 9MM VE

  • 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
 

ENCORE MEDICAL L.P. MOVATION KNEE MOVATION TIBIAL INSERT, SIZE 8, 9MM VE Back to Search Results
Model Number 292-09-708
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 01/05/2019
Event Type  Injury  
Event Description
Second revision surgery due to the patient having an infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMOVATION KNEE
Type of DeviceMOVATION TIBIAL INSERT, SIZE 8, 9MM VE
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key8271537
MDR Text Key133932395
Report Number1644408-2019-00068
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912112437
UDI-Public(01)00888912112437
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Model Number292-09-708
Device Catalogue Number292-09-708
Device Lot Number328N1007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/23/2019 Patient Sequence Number: 1
-
-