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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT WITH HEXALOBULA

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT WITH HEXALOBULA Back to Search Results
Catalog Number 114700
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 11/22/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to an infection. The date of the original surgery is unknown, therefore the in-vivo length of service can not be determined. There are no reported pre-existing patient health conditions. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. The invoice with the part and lot number of the device involved in this event was not provided. To adequately investigate this event, the part and/or lot number(s) are necessary. In addition to the lot and/or part number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied. The root cause of this complaint was a revision surgery due to an infection. There are multiple factors that may contribute to an infection that are outside of the control of djo surgical. With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection. Containment based on the information submitted with this complaint it is not possible.
 
Event Description
Revision surgery - due to the patient having an infection. The surgeon replaced the poly and humeral condyles for a poly revision.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT WITH HEXALOBULA
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 Key7105872
MDR Text Key271518348
Report Number1644408-2017-01143
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912224833
UDI-Public(01)00888912224833
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051975
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 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2018
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: 12/11/2017 Patient Sequence Number: 1
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