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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. BIOMET DISCOVERY ELBOW DISC CONDYLE KIT W ALIGNMENT

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ENCORE MEDICAL, L.P. BIOMET DISCOVERY ELBOW DISC CONDYLE KIT W ALIGNMENT Back to Search Results
Catalog Number 114990
Device Problems Naturally Worn (2988); Torn Material (3024)
Patient Problem No Code Available (3191)
Event Date 03/29/2016
Event Type  Injury  
Event Description
Revision surgery - due to normal wear and tear on the poly and bearings.
 
Manufacturer Narrative
The reason for this revision surgery was normal wear/tear on poly and bearings. The original surgery date is not available; the implant in-vivo length of patient service could not be determined. 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 search of the djo surgical patient database was not conducted since biomet products and surgeries are presently not included in the djo historical surgical records. No complaint history is available at this time. Zimmer was contacted to provide support documentation and additional information. Zimmer could not identify the patient or provide additional historical information for this complaint. This event is deemed to be non-product related. The report of this complaint states the patient had normal wear and tear on the poly and bearings. 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 NameBIOMET DISCOVERY ELBOW
Type of DeviceDISC CONDYLE KIT W ALIGNMENT
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 Key5606498
MDR Text Key43585468
Report Number1644408-2016-00244
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 03/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114990
Device Lot Number116190
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 Received05/31/2016
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: 04/25/2016 Patient Sequence Number: 1
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