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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 Problems Fracture (1260); Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 06/10/2016
Event Type  Injury  
Event Description
Revision surgery - due to the humeral component loosening, and a fracture on the humerus.
 
Manufacturer Narrative
The reason for this revision surgery was device loosening and a fracture on the humerus. 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 djo surgical 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 djo surgical 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 complaint states the patient's humeral component was loosening and there was a fracture on the humerus after an unspecified length of in-vivo service. The root cause relating to this event was not reported and could not be determined with confidence. The surgeon reported no issues associated with the explanted product. 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 NameDISCOVERY ELBOW
Type of DeviceDISC HUM 4X100MM LT 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 Key5778950
MDR Text Key49067613
Report Number1644408-2016-00442
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225465
UDI-Public(01)00888912225465
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 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2016
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 Received07/19/2016
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: 07/08/2016 Patient Sequence Number: 1
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