Brand Name | JOURNEY UNI TIBINRT S1-2RM/LL8MM |
Type of Device | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
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 |
claudia
odoy
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
0628320660
|
|
MDR Report Key | 6137829 |
MDR Text Key | 61227064 |
Report Number | 1020279-2016-00923 |
Device Sequence Number | 1 |
Product Code |
HSX
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K061011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
02/19/2018 |
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 Catalogue Number | 71422245 |
Device Lot Number | 16CM14702 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/15/2016 |
Initial Date FDA Received | 12/01/2016 |
Supplement Dates Manufacturer Received | Not provided 11/29/2017 11/29/2017
|
Supplement Dates FDA Received | 03/03/2017 11/30/2017 02/19/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/21/2016 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 77 YR |
Patient Weight | 75 |