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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE EMPOWR 3D KNEETM INS, 9L 16MM, VE

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ENCORE MEDICAL L.P. EMPOWR 3D KNEE EMPOWR 3D KNEETM INS, 9L 16MM, VE Back to Search Results
Model Number 341-16-709
Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 04/16/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to instability. The previous surgery and the revision detailed in this investigation occurred 19 days 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. Initial or prolonged hospitalization was required. 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. The root cause of this complaint was a revision surgery due to instability. 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 event. There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: poor bone density, inadequate soft tissue support, patient bone deterioration, degenerative bone disease, patient activities or trauma. Due to the short time between the previous and revision surgery, the event may have possibly occurred due to improper surgical technique, patient non-compliance with medical instructions. 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 NameEMPOWR 3D KNEE
Type of DeviceEMPOWR 3D KNEETM INS, 9L 16MM, VE
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 Key8608373
MDR Text Key145009925
Report Number1644408-2019-00428
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912167161
UDI-Public(01)00888912167161
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/17/2021
Device Model Number341-16-709
Device Catalogue Number341-16-709
Device Lot Number153T1005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2016
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: 05/14/2019 Patient Sequence Number: 1
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