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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL LP DISCOVERY ELBOW DISC ULNA BEARING KIT

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ENCORE MEDICAL LP DISCOVERY ELBOW DISC ULNA BEARING KIT Back to Search Results
Catalog Number 114800
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 05/28/2021
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event Description
Revision surgery - surgeon determined pre-operatively that the ulna component was likely loose and scheduled revision surgery. The original condyle kit and ulna components were removed and the items were implanted.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA BEARING KIT
Manufacturer (Section D)
ENCORE MEDICAL LP
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL LP
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
kiersten soderman
9800 metric blvd
austin, TX 78758-5445
MDR Report Key12028695
MDR Text Key257204622
Report Number1644408-2021-00595
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 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/11/2021
Device Catalogue Number114800
Device Lot Number459160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2016
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: 06/18/2021 Patient Sequence Number: 1
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