Brand Name | TRIAL FEMORAL HEAD 36 S/+0 |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
aarau CH-50 00 |
SZ CH-5000 |
|
MDR Report Key | 11061167 |
MDR Text Key | 223378483 |
Report Number | 9613369-2020-00272 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 07611996121896 |
UDI-Public | 07611996121896 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
03/19/2021 |
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 | 75100856 |
Device Catalogue Number | 75100856 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/26/2020
|
Initial Date FDA Received | 12/22/2020 |
Supplement Dates Manufacturer Received | 12/09/2020 03/16/2021
|
Supplement Dates FDA Received | 12/27/2020 03/19/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|