Brand Name | EMPOWR 3D KNEE |
Type of Device | EMPOWR 3D KNEETM, PRESS FIT FEMUR, 8L |
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 | 10276647 |
MDR Text Key | 198929670 |
Report Number | 1644408-2020-00591 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 00190446231295 |
UDI-Public | (01)00190446231295 |
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 |
07/15/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/15/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 243-01-108 |
Device Catalogue Number | 243-01-108 |
Device Lot Number | 277W1026 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 06/17/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/11/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 341-14-709 LOT 133T1021 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 59 YR |
|
|