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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 W/ HEXALOBULA

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA Back to Search Results
Catalog Number 114700
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 11/29/2016
Event Type  Injury  
Event Description
Revision surgery - due to the patient having an infection.
 
Manufacturer Narrative
The incorrect part, 114700, was provided and reported in the initial medical device report; the part provided was that of the device implanted during the revision surgery. The reason for this revision surgery was an infection. The date of the original surgery is unknown, so the in-vivo length of service could not be calculated. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the possible infection or inhibited the patient's immune system. 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. This investigation is limited in scope as limited information was provided to djo surgical - austin for review. 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 are necessary. In addition to the lot number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied. If this information is submitted at a future date, this investigation will be re-evaluated. 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/root cause of the infection.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT W/ HEXALOBULA
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key6200686
MDR Text Key63176780
Report Number1644408-2016-01009
Device Sequence Number1
Product Code JDC
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 01/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
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?
Event Location No Information
Date Manufacturer Received01/17/2017
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: 12/22/2016 Patient Sequence Number: 1
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