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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE FEMUR, NONPOROUS, 3D, SIZE6, LT

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ENCORE MEDICAL L.P. 3D KNEE FEMUR, NONPOROUS, 3D, SIZE6, LT Back to Search Results
Model Number 391-09-606
Device Problem Device Inoperable (1663)
Patient Problem Loss of Range of Motion (2032)
Event Date 02/22/2010
Event Type  Injury  
Manufacturer Narrative

This mdr is being reported after learning about a potential device related event following a review of clinical study records. The internal standard operating procedure for complaint reporting has been updated to reflect a requirement for all clinical study events to be handled in the same manner as all product complaints.

 
Event Description

Reported incident - due to left knee failure, limited range of motion.

 
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Brand Name3D KNEE
Type of DeviceFEMUR, NONPOROUS, 3D, SIZE6, LT
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 Key7397356
MDR Text Key104382037
Report Number1644408-2018-00291
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032905
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 07/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2015
Device MODEL Number391-09-606
Device Catalogue Number233-01-106
Device LOT Number54042692
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2009
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: 04/04/2018 Patient Sequence Number: 1
Treatment
130-03-026, LOT 54035988; 233-01-106, LOT 54042692; 323-01-104, LOT A1000000
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