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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X200MM LT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X200MM LT FLANGED C Back to Search Results
Catalog Number 114924
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/02/2018
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to the humeral component being loose. The previous surgery date is unknown therefore the time between surgeries could not be determined. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. 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 the hospital and not made available to djo surgical for examination. A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event. As of 20-feb-2018, the records needed to verify an acceptable sterilization process have not been forwarded by zimmer-biomet. Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to the humeral component being loose. There were no findings during this investigation that indicate that the reported device was defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the humeral component being loose. The surgeon removed and replaced it.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 4X200MM 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
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key7186418
MDR Text Key277969921
Report Number1644408-2018-00041
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 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2020
Device Catalogue Number114924
Device Lot Number532790
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2010
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: 01/12/2018 Patient Sequence Number: 1
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