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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 5X100MM LT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 5X100MM LT FLANGED C Back to Search Results
Catalog Number 114906
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 01/31/2018
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to poor bone quality and cement interdigitation. The original surgery date was not provided or could be established, so the length of in-vivo could not be determined. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. 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. A review of the device history record (dhr) was not conducted since a item and or lot number was not provided or determined during the complaint evaluation. No additional information was obtained to assist in the event identification. As of 12-mar-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 poor bone quality and cement interdigitation. 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 surgeon finding that the patient had poor bone quality and cement interdigitation. The representative indicated that the first surgery was long ago prior to djo getting the elbow system and no records could be found.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 5X100MM LT FLANGED C
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 Key7259978
MDR Text Key277514796
Report Number1644408-2018-00119
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 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114906
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 Received03/12/2018
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: 02/09/2018 Patient Sequence Number: 1
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