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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 6LT 9MM

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ENCORE MEDICAL L.P 3DKNEE INSERT, 3D EX SZ 6LT 9MM Back to Search Results
Model Number 391-09-706
Device Problem Unstable (1667)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was instability. The in-vivo length of patient service for the implant was 6. 3 months. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. 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), shows that the reported component(s) used in the previous surgery met design and manufacturing requirements. There were no ncmrs associated with the product(s) that may have contributed to the reported event. The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device(s) showed no present trends or on-going issues that are in need of review. This event is deemed to be non-product related. The root cause of this complaint was a revision surgery due to instability. 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 event. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to instability.
 
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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 Key7205447
MDR Text Key274998691
Report Number1644408-2018-00050
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 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2019
Device Model Number391-09-706
Device Catalogue Number391-09-706
Device Lot Number59605199
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 Received02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2014
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: 01/19/2018 Patient Sequence Number: 1
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