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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, 5R

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ENCORE MEDICAL L.P. EMPOWR POROUS KNEE; EMPOWR 3D KNEETM, PRESS FIT FEMUR, 5R Back to Search Results
Model Number 243-02-105
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Loss of Range of Motion (2032)
Event Date 06/30/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as patient lacked range of motion.The previous surgery and the surgery detailed in this event occurred 11.2 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 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 patient lacked range of motion.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.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Revision surgery - the patient was revised because the patient lacked range of motion.
 
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Brand Name
EMPOWR POROUS KNEE
Type of Device
EMPOWR 3D KNEETM, PRESS FIT FEMUR, 5R
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 Key10332168
MDR Text Key200768829
Report Number1644408-2020-00621
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00190446231363
UDI-Public(01)00190446231363
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171991
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 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number243-02-105
Device Catalogue Number243-02-105
Device Lot Number284W1017
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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