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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 Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2019
Event Type  Injury  
Event Description
Revision surgery due to loosening of components.
 
Manufacturer Narrative
(b)(4). Manufacturer narrative: the reason for this revision surgery was due to loosening. The previous surgery and the surgery detailed in this investigation occurred 1. 1 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 item: 114906 device history record (dhr) was not conducted since as of (b)(6)2019, no records have been made available. Should the records needed for review become available, the complaint will be re-opened and a review will be conducted. 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 loosening. The surgeon performed this procedure to remedy the patient's condition. 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.
 
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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 Key8388332
MDR Text Key137785456
Report Number1644408-2019-00158
Device Sequence Number0
Product Code JDC
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 05/22/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114700
Device Lot Number201750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
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: 03/04/2019 Patient Sequence Number: 1
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