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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 7LT 9MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 7LT 9MM Back to Search Results
Model Number 391-09-707
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/06/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery is due to an infection. The previous surgery and the revision detailed in this investigation occurred 3 years 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 (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery. 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. 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 the patient having an infected knee. The patient underwent a washout and poly exchange.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 7LT 9MM
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 Key7134612
MDR Text Key149368086
Report Number1644408-2017-01182
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091956
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 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2019
Device Model Number391-09-707
Device Catalogue Number391-09-707
Device Lot Number59605201
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 Received01/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2014
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: 12/20/2017 Patient Sequence Number: 1
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