Brand Name | RENASYS GO |
Type of Device | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull |
UK |
|
MDR Report Key | 8313624 |
MDR Text Key | 135367470 |
Report Number | 8043484-2019-00089 |
Device Sequence Number | 1 |
Product Code |
HRY
|
Combination Product (y/n) | N |
PMA/PMN Number | K152163 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
03/18/2019 |
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 Catalogue Number | 66801496 |
Device Lot Number | KHBM160127 |
Initial Date Manufacturer Received |
01/17/2019
|
Initial Date FDA Received | 02/06/2019 |
Supplement Dates Manufacturer Received | 01/17/2019
|
Supplement Dates FDA Received | 03/18/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|