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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM LT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM LT FLANGED C Back to Search Results
Catalog Number 114904
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 12/09/2016
Event Type  Injury  
Event Description
Revision surgery - due to the humeral component loosening; the surgeon was not sure why.
 
Manufacturer Narrative
The reason for this revision surgery was loosening of the humeral component. The length of in-vivo patient service for this product was 2. 8 years. The complaint reports no issues of any other patient injuries, activities, accidents or manufacturing contraindicants that may have been contributory to this surgery. No reported pre-existing patient health conditions. The healthcare professional indicated there was a significant adverse event to the patient. 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 lot number was not provided or determined during the complaint evaluation. A search of the device investigation history produced no anomalies or evidence of a product issue. Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event. Zimmer-biomet was contacted for additional information through an invoice search and only reported a part number. This complaint is deemed to be non-product related. The root cause for the loose humeral component was not reported. No other conditions relating to this event could be determined with confidence. The surgeon reported no issues associated with the explanted product. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 4X100MM 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
5128346255
MDR Report Key6231235
MDR Text Key64126639
Report Number1644408-2016-01059
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 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114904
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 Received03/02/2017
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: 01/06/2017 Patient Sequence Number: 1
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