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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 11/10/2016
Event Type  Injury  
Event Description
Revision surgery - due to an infection; with a staged revision. Stage 1 was performed on (b)(6) 2016 and was the removal of the poly and condyle and the insertion of antibiotic beads. The original surgery took place 6 to 7 years prior. Stage 2 of the surgery was on (b)(6) 2016 and was the removal of the antibiotic beads and reimplantation of poly and condyles.
 
Manufacturer Narrative
The reason for this revision surgery was a staged revision due to an infection. Stage 1 was performed (b)(6) 2016 and was the removal of a poly and condyle and insertion of antibiotic beads. Stage 2 of surgery on (b)(6) 2016 was the removal of the antibiotic beads and reimplantation of poly and condyles. The original surgery took place 6 to 7 years prior; the exact date of the original surgery is unknown. The healthcare professional indicated there was no delay in surgery and the revision surgery was completed as intended. The device was disposed of at the hospital and not made available to (b)(4) for examination. The lot numbers of the devices involved in this event were not provided. To adequately investigate this event, the lot numbers are necessary. In addition to the lot numbers 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. Attempts were made to obtain the lot numbers of the devices that were removed; however, this information was not available. Without this information, this investigation is limited in scope. The reason of this complaint was a revision surgery due to an infection. 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 infection or inhibited the patient's immune system. There are multiple factors that may contribute to an infection that are outside of the control of (b)(4). 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 Key6187644
MDR Text Key62795391
Report Number1644408-2016-01049
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 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
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 Received02/06/2017
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: 12/19/2016 Patient Sequence Number: 1
Treatment
114833
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