Brand Name | GII C/R HA POROUS FEM SZ 5RT |
Type of Device | GENESIS II TOTAL KNEE SYSTEM |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
yagna
angirish
|
1450 brooks rd |
memphis, TN 38116
|
9013995009
|
|
MDR Report Key | 5903349 |
MDR Text Key | 52965509 |
Report Number | 1020279-2016-00667 |
Device Sequence Number | 1 |
Product Code |
MBH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K030612 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Attorney
|
Type of Report
| Initial,Followup |
Report Date |
07/27/2016 |
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 | 01/01/2022 |
Device Catalogue Number | 71422030 |
Device Lot Number | 11LM07863 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/27/2016 |
Initial Date FDA Received | 08/25/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/06/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/04/2012 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 52 YR |