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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X75MM RT W BRNG C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X75MM RT W BRNG C Back to Search Results
Catalog Number 114813
Device Problem Contamination (1120)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 12/14/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to an infection. The previous surgery and the revision detailed in this investigation occurred 22 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 device history record (dhr) and the verification of acceptable sterilization process could not conducted as the records needed for review were not provided during this complaint evaluation. As of 9-feb-2018, no records have been forwarded by zimmer-biomet. Should the records be provided at a later time, this investigation will be updated or amended. 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. The surgeon removed and replaced the poly from the ulna component and the humeral condyle kit.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 3X75MM RT W BRNG C
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 Key7150899
MDR Text Key273868198
Report Number1644408-2017-01225
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225151
UDI-Public(01)00888912225151
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,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114813
Device Lot Number691100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2018
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: 12/28/2017 Patient Sequence Number: 1
Treatment
114700, LOT 216390
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