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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 Contamination (1120)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 01/14/2018
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as an infection. The date of the original surgery is unknown and therefore, the in-vivo length of service cannot be determined. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system. 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. No information was submitted regarding the patient. As of (b)(4)-2018, no records have been forwarded by zimmer-biomet concerning this event. Should zimmer-biomet provide additional information at a later time, this investigation shall be re-evaluated. The root cause of this complaint was a revision surgery due to an infection. There are multiple factors that may contribute to an infection that are outside of the control of djo surgical. With the limited information provided about the patient and the devices removed during the revision surgery, it is impossible to determine the source of the infection. Containment based on the information submitted with this complaint it is not possible as the agent was unable to supply the lot numbers.
 
Event Description
Revision surgery - due to the patient having an infection. The surgeon exchanged the busing and condyle kit.
 
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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 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 Key7205371
MDR Text Key148979805
Report Number1644408-2018-00052
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225083
UDI-Public(01)00888912225083
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 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
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? No
Event Location No Information
Date Manufacturer Received02/12/2018
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: 01/19/2018 Patient Sequence Number: 1
Treatment
114700
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