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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L. P. DISCOVERY ELBOW DISC HUM 5X100MM LT FLANGED C

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ENCORE MEDICAL L. P. DISCOVERY ELBOW DISC HUM 5X100MM LT FLANGED C Back to Search Results
Catalog Number 114906
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Joint Laxity (4526)
Event Date 02/02/2021
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 - due to humeral stem became loose. Removed humeral component and replaced with another, bigger size and a new condyle kit.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 5X100MM LT FLANGED C
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
kiersten soderman
9800 metric blvd
austin, TX 78758-5445
MDR Report Key11412400
MDR Text Key234678651
Report Number1644408-2021-00161
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 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114906
Device Lot Number325810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2015
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: 03/04/2021 Patient Sequence Number: 1
Treatment
114700, LOT 020840
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