Brand Name | ANTHEM FEMORAL PS COCR SZ 5 RT N |
Type of Device | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks rd. |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks rd. |
|
memphis TN 38116 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 15394203 |
MDR Text Key | 299893444 |
Report Number | 1020279-2022-04047 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 00885556531280 |
UDI-Public | 00885556531280 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K142807 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/26/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 71422825 |
Device Catalogue Number | 71422825 |
Device Lot Number | 22DB00320 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/22/2022
|
Initial Date FDA Received | 09/09/2022 |
Supplement Dates Manufacturer Received | 09/26/2022
|
Supplement Dates FDA Received | 09/27/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/08/2022 |
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 |
|
|