Brand Name | EMPOWR KNEE OFFSET PATELLA DRILL GUIDE, LARGE |
Type of Device | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL |
Manufacturer (Section D) |
ENCORE MEDICAL L.P |
9800 metric blvd |
austin TX 78758 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P |
9800 metric blvd |
|
austin TX 78758 |
|
Manufacturer Contact |
james
mcmahon
|
9800 metric blvd |
austin, TX 78758
|
|
MDR Report Key | 17243851 |
MDR Text Key | 318264940 |
Report Number | 1644408-2023-00821 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 00190446365891 |
UDI-Public | 00190446365891 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K212941 |
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 |
07/27/2023 |
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 | 802-05-107 |
Device Catalogue Number | 802-05-107 |
Device Lot Number | 388620L02 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 06/30/2023 |
Supplement Dates Manufacturer Received | 07/13/2023
|
Supplement Dates FDA Received | 07/27/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | 802-05-103 LOT: N/A; 802-05-103 LOT: 254340L01 |
Patient Outcome(s) |
Other;
|
Patient Age | 61 YR |
Patient Sex | Male |