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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 6X100MM RT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 6X100MM RT FLANGED C Back to Search Results
Catalog Number 114909
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as loosening. Initial implant done approximately 5 yrs prior. The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established. 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 was disposed of at hospital and not made available to djo surgical for examination. The revised item was not returned for examination and the lot number was not provided. To adequately investigate this event, the lot number was 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 loosening. There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event. This complaint will be closed pending receipt of additional information.
 
Event Description
Revision surgery - revision of humeral component due to loose component. Initial implant done approximately 5 years prior.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 6X100MM RT 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
teffany hutto
9800 metric blvd
austin, tx 78758-5445, 
MDR Report Key9750340
MDR Text Key180832387
Report Number1644408-2020-00107
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 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114909
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 Received01/28/2020
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: 02/25/2020 Patient Sequence Number: 1
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