Brand Name | GNS II CMT TIB SIZE 4 LEFT |
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 | 19016744 |
MDR Text Key | 339081949 |
Report Number | 1020279-2024-00640 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 03596010206268 |
UDI-Public | 03596010206268 |
Combination Product (y/n) | N |
Reporter Country Code | SF |
PMA/PMN Number | K951987 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/30/2024 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 71420166 |
Device Lot Number | 16FT71956 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/06/2024
|
Initial Date FDA Received | 04/01/2024 |
Supplement Dates Manufacturer Received | 04/26/2024
|
Supplement Dates FDA Received | 04/30/2024
|
Date Device Manufactured | 06/24/2016 |
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 | DEPUY BNE CMNT(PN:3095-040,LN:8317800); GNS II RSRF PAT32MM(PN:71420576,LN:16FM18029); LGN CR OXN SZ4N LT(PN:71421244,LN:12MM00713); LGN XLP INSRT SZ3-4 9MM(PN:71453111,LN:16AM17002); QCK CNCT TROC PIN 1/8X3(PN:74012904,LN:16LM09254) |
Patient Age | 76 YR |
Patient Sex | Female |
|
|