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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 RT FLANGED C

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC HUM 4X100MM RT FLANGED C Back to Search Results
Catalog Number 114905
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 06/06/2016
Event Type  Injury  
Event Description
Revision surgery - due to the patient fracturing their elbow and the implant becoming loose.
 
Manufacturer Narrative
The reason for this revision surgery was the patient fractured their elbow and the implant became loose. The length of in-vivo service is unknown since the original surgery date was not provided with the complaint and could not be established. 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 (dhr) was not conducted since a lot number was not provided or could be determined. Multiple searches of the (b)(4) records and patient database produced no additional information concerning this event. The complaint investigation history records were reviewed and no trends or on-going issues were deemed as present or in need of review. This complaint is non-product related. The root cause for the implant becoming loose was reported as an elbow fracture. 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.
 
Manufacturer Narrative
Additional information was requested from zimmer-biomet based on patient name. After receipt of new information, it was determined that this complaint is a duplicate of (b)(4) that was assigned medical device report number (mdr)# 1644408-2016-00422. Mdr 1444408-2016-00526 is being voided and the complaint will be closed with a quantity of 0 on the affected items.
 
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Brand NameDISCOVERY 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 Key5799746
MDR Text Key49743407
Report Number1644408-2016-00526
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225472
UDI-Public(01)00888912225472
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,Followup
Report Date 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
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 Received10/04/2016
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: 07/15/2016 Patient Sequence Number: 1
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