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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE HXL-VE 3D INSERT 10LX11MM

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ENCORE MEDICAL L.P. 3DKNEE HXL-VE 3D INSERT 10LX11MM Back to Search Results
Model Number 391-11-710
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Information (3190)
Event Date 12/14/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to loosening. The previous surgery and the revision detailed in this investigation occurred over 4 years and 1 month apart. 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 a non-conforming material report (ncmr) # (b)(4) associated with the part 391-11-710, 3d knee hxl ve poly tibial insert, size 10 which documents a nonconformance that out of 14 quantity lot all items were rejected due to the presence of flash in the cruciate notch. Rejected items were reworked with suitable operations and were accepted. All items in the lot have met the fit design and functional requirements. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to loosening. There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's loosening. There are many factors that may contribute to the event that are outside the control of djo surgical such as: loose joints from inadequate soft tissue support, degenerative bone, patient bone deterioration, patient activities or trauma. 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 the patient having mid-flexion loosening. A thicker insert was needed.
 
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Brand Name3DKNEE
Type of DeviceHXL-VE 3D INSERT 10LX11MM
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 Key7148072
MDR Text Key195843797
Report Number1644408-2017-01210
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 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Model Number391-11-710
Device Catalogue Number391-11-710
Device Lot Number59601277
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 Received02/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2011
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: 12/27/2017 Patient Sequence Number: 1
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