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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 Contamination (1120)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as an infection. The previous surgery and the revision detailed in this investigation occurred 32 days apart. 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. A review of the implant device history records (dhr) and verification of an acceptable sterilization process could not be conducted. The records needed for review were not made available at the time of this investigation. As of 15-feb-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. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection. Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial). It is also possible that the patient was not compliant with post surgical instructions. There are multiple factors that may contribute to an infection that are outside of the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to an infection.
 
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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
MDR Report Key7234065
MDR Text Key280686732
Report Number1644408-2018-00104
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K051975
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114700
Device Lot Number229590
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/01/2018 Patient Sequence Number: 1
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