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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 4X100MM RT FLANGED C

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ENCORE MEDICAL, L.P. BIOMET DISCOVERY ELBOW DISC HUM 4X100MM RT FLANGED C Back to Search Results
Catalog Number 114905
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 02/01/2016
Event Type  Injury  
Event Description
Revision surgery - the patient had a total shoulder implanted after the initial elbow was implanted. There was some interference with the distal end of the shoulder implant stem and the proximal portion of the elbow stem on the humeral side. In (b)(6) 2013, a revision was done where the surgeon had to cut the proximal portion of the elbow humeral stem to make it fit better, so there was no interference with the shoulder implant. The patient has experienced some loosening with the elbow humeral component. The surgeon removed the old humeral component and condyle implants from the elbow. Placed a strut on the distal end of the humerus, cut a new 4 x 100 humeral elbow component cemented it into place and put new condyle components. In.
 
Manufacturer Narrative
The reason for this revision surgery was implant loosening; the patient had a total shoulder put in after the initial elbow was put in. There was some interference with the distal end of the shoulder implant stem and the proximal portion of the elbow stem on the humeral side. The implant in-vivo length of patient service is unknown but the (b)(4) date would indicate the in-vivo time of approximately 3 years. 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. 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 (b)(4) for examination. A review of the device history record and investigation history was not conducted since a lot number was not provided or could be established for the original explanted part. A search the (b)(4) 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 root cause for the elbow stem loosening was not reported. 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 4X100MM 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 Key5471956
MDR Text Key39423161
Report Number1644408-2016-00081
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 02/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114905
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 Received07/25/2016
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: 03/01/2016 Patient Sequence Number: 1
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