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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT Back to Search Results
Model Number V
Device Problems Break (1069); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 04/26/2016
Event Type  Injury  
Event Description
Revision surgery - due to the poly wearing out; causing the pin/screw to break. The surgeon performed a bearing surface exchange.
 
Manufacturer Narrative
The reason for this revision surgery was the pin/screw broke. The original surgery date was not provided and could not be determined, therefore; the length of in-vivo service is unknown. 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 and investigation history was not conducted since a lot number was not provided and could not be established for the original explanted part. A search of the djo surgical patient database was not conducted since biomet products and surgeries are not included in the djo historical surgical records at this time. No complaint history is available at this time. Zimmer biomet was contacted and was unable to provide any additional information concerning this revision surgery. Additional information is necessary for zimmer biomet to retrieve original surgery information and the information is unavailable at this time. The event is the result of poly wear and a subsequent screw breakage after an un-specified length of in-vivo service. This is an isolated incident and there is no reason to believe a general risk is present. The complaint evaluation is limited in scope since the part (s) associated with the complaint was not returned to djo surgical for evaluation. No other conditions relating to this event could be determined with confidence. 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 ULNA BEARING KIT
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key5676698
MDR Text Key45827595
Report Number1644408-2016-00301
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 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberV
Device Catalogue Number114800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2016
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: 05/24/2016 Patient Sequence Number: 1
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