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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. POROUS KNEE SYSTEM EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7L

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ENCORE MEDICAL L.P. POROUS KNEE SYSTEM EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7L Back to Search Results
Model Number 243-01-107
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

 
Event Description

Revision surgery - due to dislocation.

 
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Brand NamePOROUS KNEE SYSTEM
Type of DeviceEMPOWR 3D KNEETM, PRESS FIT FEMUR, 7L
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445, TX 78758-5445
MDR Report Key9379055
MDR Text Key168222200
Report Number1644408-2019-01177
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number243-01-107
Device Catalogue Number243-01-107
Device LOT Number276W1012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2018
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: 11/26/2019 Patient Sequence Number: 1
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