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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
Catalog Number 114800
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 11/21/2016
Event Type  Injury  
Event Description
Revision surgery - the patient had a revison 7 years ago and they put in a segmental revision system (srs) distal humeral replacement; this surgery was required due to a worn poly bushing.
 
Manufacturer Narrative
The concomitant part was reported as the main part number on the initial medical device report. Manufacturer narrative: the reason for this revision surgery was a worn poly bushing. The actual length of patient in-vivo service for this product is unknown as the original surgery date was not provided or could be established. The complaint, however: does indicate the implants may have been in use as much as seven years. 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. 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 lot number was not provided or determined during the complaint evaluation. A search of the device investigation produced no anomalies or evidence of a product issue. Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event. Zimmer-biomet was contacted for additional information through an invoice search and reported they have no additional information to report for this evaluation. This event is deemed to be non-product related. The root cause for poly bushing wear was not reported. The surgeon reported no issues associated with the explanted product. The scope of this investigation is limited without having the parts available to djo surgical for evaluation. Other conditions, root cause, relating to this event could not 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 Key6194920
MDR Text Key62998523
Report Number1644408-2016-00986
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 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/18/2017
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: 12/21/2016 Patient Sequence Number: 1
Treatment
114800
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