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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL LP DISCOVERY ELBOW DISC ULNA 2.5X53MM RT W/ E+ BRNG

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ENCORE MEDICAL LP DISCOVERY ELBOW DISC ULNA 2.5X53MM RT W/ E+ BRNG Back to Search Results
Model Number 540-62-053
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 06/29/2021
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Revision surgery - due to ulnar component loosening. Put new cement mantle and longer stem in.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 2.5X53MM RT W/ E+ BRNG
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 Key12159668
MDR Text Key261310876
Report Number1644408-2021-00703
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090473
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number540-62-053
Device Catalogue Number540-62-053
Device Lot Number817W1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2019
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: 07/13/2021 Patient Sequence Number: 1
Treatment
540-00-004 LOT 75737
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