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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, 7R

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ENCORE MEDICAL L.P. EMPOWR POROUS KNEE; EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7R Back to Search Results
Model Number 130-03-735
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event Description
Revision surgery - due to switched from empowr to epic.
 
Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as switching of empower knee to epic knee.The previous surgery and the surgery detailed in this event occurred 2 months and 2 weeks 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) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements and showed no non-conforming material reports (ncmr) associated with the main contributor component listed in the complaint.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 switched to empowr knee to epic knee.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 poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Manufacturer Narrative
D10 adding concomitant part 600-15-000.
 
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Brand Name
EMPOWR POROUS KNEE
Type of Device
EMPOWR 3D KNEETM, PRESS FIT FEMUR, 7R
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445, TX 78758-5445
MDR Report Key9593448
MDR Text Key175195030
Report Number1644408-2020-00015
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00888912108553
UDI-Public(01)00888912108553
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,Followup,Followup
Report Date 08/04/2022
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 Number130-03-735
Device Catalogue Number243-02-107
Device Lot Number286W1021
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received01/15/2020
Supplement Dates Manufacturer Received01/30/2020
01/30/2020
Supplement Dates FDA Received02/28/2020
08/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
130-03-735 LOT 156N1506; 243-02-107. LOT 286W1021; 342-16-707 LOT 161T1021; 342-16-707. LOT 161T1021; 353-04-107 LOT 222W1010; 353-04-107. LOT 222W1010; 600-15-000 COBALT HV BONE CEMENT 40GM; 243-02-107. LOT 286W1021; 342-16-707. LOT 161T1021; 353-04-107. LOT 222W1010
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexMale
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