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 Key | 10332168 |
MDR Text Key | 200768829 |
Report Number | 1644408-2020-00621 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 00190446231363 |
UDI-Public | (01)00190446231363 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K171991 |
Number of Events Reported | 1 |
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 Number | 243-02-105 |
Device Catalogue Number | 243-02-105 |
Device Lot Number | 284W1017 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/30/2020 |
Initial Date FDA Received | 07/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/10/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 49 YR |
|
|