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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 5LT 11MM

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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); No Code Available (3191)
Event Date 05/08/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reduced range of motion. The previous surgery and the revision detailed in this investigation occurred over 4 years and 7 months apart. 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 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 the event. 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. There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event. The root cause of this complaint was a revision surgery due to reduced range of motion. There are multiple factors that may contribute to the event that are outside the control of djo surgical are patient activities, inadequate soft tissue support, patient bone deterioration, low bone density or trauma. No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined. 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 - the patient could not attain full range of motion.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 5LT 11MM
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 Key6616488
MDR Text Key149379603
Report Number1644408-2017-00419
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119214
UDI-Public(01)00888912119214
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 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2016
Device Model Number391-11-705
Device Catalogue Number391-11-705
Device Lot Number59601788
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 Received06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2011
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: 06/06/2017 Patient Sequence Number: 1
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