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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR POROUS KNEE EMPOWR 3D KNEETM, PRESS FIT FEMUR, 9L

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ENCORE MEDICAL L.P. EMPOWR POROUS KNEE EMPOWR 3D KNEETM, PRESS FIT FEMUR, 9L Back to Search Results
Model Number 243-01-109
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Code Available (3191)
Event Date 11/22/2019
Event Type  Injury  
Manufacturer Narrative

The reason for this revision surgery was reported as loosening. The previous surgery and the surgery detailed in this event occurred 3 months and 3 weeks apart. 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 devices were disposed of at hospital and not made available to djo surgical for examination. A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event. The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery. Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to loosening. There were no findings during this evaluation that indicate the reported devices were defective. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event. There are multiple factors that may contribute to an event that are outside the control of djo surgical such as inadequate soft tissue support, excessive range of motion, poor bone density, patient bone deterioration, patient activities or trauma. There are no indications of a product or process issue affecting implant safety or effectiveness.

 
Event Description

Revision surgery - due to femoral component loosening.

 
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Brand NameEMPOWR POROUS KNEE
Type of DeviceEMPOWR 3D KNEETM, PRESS FIT FEMUR, 9L
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 Key9503813
MDR Text Key173289974
Report Number1644408-2019-01223
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number243-01-109
Device Catalogue Number243-01-109
Device LOT Number278W1021
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/18/2019
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: 12/20/2019 Patient Sequence Number: 1
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