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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fracture, Arm (2351)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as fracture. The previous surgery and the surgery detailed in this event occurred 9. 4 years apart. 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 records (dhr) was not conducted since the item or lot number was not provided or determined during the complaint evaluation. Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to a fracture. The length of in-vivo service is unknown since an original surgery date was not provided or could be established. There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event. Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - radius fracture.
 
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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 Key9050408
MDR Text Key159784732
Report Number1644408-2019-00872
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
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114700
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 Received08/15/2019
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: 09/13/2019 Patient Sequence Number: 1
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