Brand Name | EMPOWR VVC KNEE |
Type of Device | EMPOWR VVC KNEETM TIBIAL INSERT, SIZE 10, 10MM |
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 | 10528937 |
MDR Text Key | 206859986 |
Report Number | 1644408-2020-00769 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 00190446269779 |
UDI-Public | (01)00190446269779 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K180930 |
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,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 Expiration Date | 02/28/2024 |
Device Model Number | 346-10-710 |
Device Catalogue Number | 346-10-710 |
Device Lot Number | 428V1006 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/17/2020
|
Initial Date FDA Received | 09/14/2020 |
Supplement Dates Manufacturer Received | 08/17/2020
|
Supplement Dates FDA Received | 08/04/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/06/2019 |
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 | 130-03-738 LOT 157N1324; 600-15-100 COBALT G-HV BONE CEMENT 40GM; 130-03-738 LOT 157N1324 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 85 YR |
Patient Sex | Male |