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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to pain. It was reported the previous surgery occurred 10 years ago. No records of the previous surgery were forwarded for review. The complaint reports no issues of any other patient injuries, activities, accidents that may have been contributory to this surgery. No reported pre-existing patient health conditions. The complaint reported no surgical delays during the revision surgery. The surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. A review of the device history record (dhr) was not conducted since the lot number was not provided or determined during the complaint evaluation. No additional information was obtained to assist in the event identification. As of (b)(6) 2018, no records have been forwarded by zimmer-biomet concerning this event. Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted. The root cause of this complaint was a revision surgery due to pain. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the patient experiencing pain.
 
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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 Key7140059
MDR Text Key262857951
Report Number1644408-2017-01212
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225083
UDI-Public(01)00888912225083
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 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114800
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 Received02/05/2018
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: 12/21/2017 Patient Sequence Number: 1
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