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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. BIOMET DISCOVERY ELBOW DISC HUM 6X100MM RT FLANGED C

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ENCORE MEDICAL, L.P. BIOMET DISCOVERY ELBOW DISC HUM 6X100MM RT FLANGED C Back to Search Results
Catalog Number 114909
Device Problem Fracture (1260)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 03/10/2016
Event Type  Injury  
Event Description
Revision surgery due to the patient falling and causing a periprosthetic fracture.
 
Manufacturer Narrative
The reason for this revision surgery was a ulna fracture. The in-vivo length of patient implant service is unknown without the original surgery date which is unknown or not established. 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 revealed no issues in the manufacture of this product. A search the djo surgical patient database was not conducted since biomet products and surgeries are not included at this time in the historical records. This event is deemed to be non-product related. The complaint states the patient fell and caused a peri-prosthetic fracture. The scope is limited since the part (s) associated with the complaint was not returned to djo surgical for evaluation. No other conditions relating to this event could be determined with confidence. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand NameBIOMET DISCOVERY ELBOW
Type of DeviceDISC HUM 6X100MM RT FLANGED C
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 Key5551840
MDR Text Key41998456
Report Number1644408-2016-00196
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 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114909
Device Lot Number231740
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 Received06/06/2016
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: 04/06/2016 Patient Sequence Number: 1
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