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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT Back to Search Results
Catalog Number 114800
Device Problem Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as poly wear. The date of the original surgery is unknown. 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 were disposed of at the hospital and not made available to djo surgical for examination. This investigation is limited in scope as limited information was provided to djo surgical - austin for review. The part and or lot number of the devices involved in this event was not provided. To adequately investigate this event, the part and or lot numbers are necessary. If this information is submitted at a future date, this investigation will be re-evaluated. The root cause of this complaint was a revision surgery due to poly wear. No other information was submitted regarding the patient. Additional information about the devices that was removed during this revision surgery was not provided. The surgeon performed this revision to remedy the patient's condition.
 
Event Description
Revision surgery - revision due to poly wear. Unla bearing and condyle kit replaced. (original surgery done in 2011 with biomet).
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA BEARING KIT
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 
MDR Report Key9139332
MDR Text Key161786516
Report Number1644408-2019-00954
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 Non-Healthcare Professional
Type of Report Initial
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114800
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
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: 10/01/2019 Patient Sequence Number: 1
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