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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 2.5X53MM RT BOND CT

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 2.5X53MM RT BOND CT Back to Search Results
Catalog Number 114803
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 07/02/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was an infection. The previous surgery and the surgery detailed in this investigation occurred 39 days apart. 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, shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements. There were no nonconforming material reports associated with the product that may have contributed to the reported event. The device was within its expiration date at the time of the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was reported as an infection. There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's infection. 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 possible infection or inhibited the patient's immune system. 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 superficial infection. The case was an irrigaion & drainage washout with ball bearing exchange.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 2.5X53MM RT BOND CT
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 Key8852738
MDR Text Key153074038
Report Number1644408-2019-00733
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114803
Device Lot Number791640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2016
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: 08/01/2019 Patient Sequence Number: 1
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