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ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 5LT 11MM Back to Search Results
Model Number 391-11-705
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Failure of Implant (1924); Injury (2348); No Code Available (3191)
Event Date 08/09/2017
Event Type  Injury  
Event Description
Revision surgery - due to the patient having crushed her tibia; the implants became loose.No information was given to representative on how the patient became injured and the information was very vague on when the first surgery occurred.They were only told 5 plus years ago at the same hospital, but no past information was found in our djo records.
Manufacturer Narrative
The reason for this revision surgery was the patient crushed her tibia and the implants came loose.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established.The complaint does indicate the product may have been implanted approximately five years ago.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 record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation.Multiple searches of the djo surgical records by surgeon and patient database revealed no additional information concerning this event.No additional information was obtained from the agent to assist in the event identification.This event is deemed as non-product related.The complaint states the patient crushed her tibia and implants came loose.The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation.No information was given to rep on how the patient became injured and information was very vague on when the first surgery occurred.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.
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Brand Name
Type of Device
Manufacturer (Section D)
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key6853408
MDR Text Key85457124
Report Number1644408-2017-00757
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119214
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number391-11-705
Device Catalogue Number391-11-705
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
336-01-106,LOT UNKNOWN
Patient Outcome(s) Required Intervention;
Patient Age58 YR