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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE EMPOWR 3D KNEETM, PRESS FIT FEMUR, 4L

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ENCORE MEDICAL L.P. EMPOWR 3D KNEE EMPOWR 3D KNEETM, PRESS FIT FEMUR, 4L Back to Search Results
Model Number 243-01-104
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Pain (1994)
Event Date 09/08/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Revision surgery - the patient's total knee was revised for pain and what appeared to be a loose femur. The patient had a car accident and believes that's when the pain began.

 
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Brand NameEMPOWR 3D KNEE
Type of DeviceEMPOWR 3D KNEETM, PRESS FIT FEMUR, 4L
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 Key10634775
MDR Text Key209982505
Report Number1644408-2020-00884
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 11/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number243-01-104
Device Catalogue Number243-01-104
Device LOT Number273W1010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2018
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: 10/06/2020 Patient Sequence Number: 1
Treatment
341-10-704 LOT 064T1009
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