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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT WITH HEXALOBULA

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT WITH HEXALOBULA Back to Search Results
Catalog Number 114700
Device Problems Fracture (1260); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to loosening and fracture of the prosthesis. The previous surgery and the revision detailed in this investigation occurred over 3 years apart. 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 device history record (dhr) was not conducted since a item/lot number(s) was not provided or determined during the complaint evaluation. No additional information was obtained to assist in the event identification. As of (b)(6) 2018, no records have been forwarded by zimmer-biomet concerning this event. Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted. The root cause of this complaint was a revision surgery due to loosening and fracture of the prosthesis. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to the patient loosening as well as having a fracture to the prosthesis. The surgeon decided to do a revision. The representative indicated the first surgery was (b)(6) 2014, but no records could be located in our database for this patient with that date or doctor or hospital.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT WITH HEXALOBULA
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 Key7146482
MDR Text Key263795808
Report Number1644408-2017-01209
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051975
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 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114700
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 Received02/02/2018
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: 12/26/2017 Patient Sequence Number: 1
Treatment
114839
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