• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 6LT 9MM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 6LT 9MM Back to Search Results
Model Number 391-09-706
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 04/03/2018
Event Type  Injury  
Event Description
Revision surgery - due to the patient being infected.
 
Manufacturer Narrative
The reason for this revision surgery was reported as an infection. The previous surgery and the revision detailed in this investigation occurred 4. 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. Initial or prolonged hospitalization was required. The healthcare professional indicated there was a significant adverse event to the patient. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 6LT 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 Key7423402
MDR Text Key105237391
Report Number1644408-2018-00327
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912118965
UDI-Public(01)00888912118965
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 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2018
Device Model Number391-09-706
Device Catalogue Number391-09-706
Device Lot Number59603992
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 Received04/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2013
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: 04/11/2018 Patient Sequence Number: 1
-
-