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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 4LT 9MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 4LT 9MM Back to Search Results
Model Number 391-09-704
Device Problem Unstable (1667)
Patient Problem No Code Available (3191)
Event Date 08/30/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to the patient becoming unstable. The in-vivo length of patient service for the implant was 1. 5 years. 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 device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part. All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. This event is deemed as non-product related. The root cause for this event was the patient had become unstable. The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation. Other conditions relating to this event could not be determined with confidence. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to patient becoming unstable.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 4LT 9MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key6905089
MDR Text Key153231585
Report Number1644408-2017-00829
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912118941
UDI-Public(01)00888912118941
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 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Model Number391-09-704
Device Catalogue Number391-09-704
Device Lot Number281G1906
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 Received10/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2014
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: 09/29/2017 Patient Sequence Number: 1
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