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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT Back to Search Results
Catalog Number 114800
Device Problem Structural Problem (2506)
Patient Problem Failure of Implant (1924)
Event Date 12/31/2018
Event Type  Injury  
Event Description
Revision surgery - due to catastrophic poly ethelene failure.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA BEARING KIT
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 Key8261760
MDR Text Key133565206
Report Number1644408-2019-00040
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013042
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 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114800
Device Lot Number016600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/18/2019 Patient Sequence Number: 1
Treatment
114800, LOT 016600
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