Brand Name | POLARSTEM STEM LAT.TI/HA 3 NON-CEM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
aarau CH-50 00 |
SZ CH-5000 |
|
MDR Report Key | 11058847 |
MDR Text Key | 223369266 |
Report Number | 9613369-2020-00266 |
Device Sequence Number | 1 |
Product Code |
LWJ
|
UDI-Device Identifier | 07611996118674 |
UDI-Public | 07611996118674 |
Combination Product (y/n) | N |
PMA/PMN Number | K130728 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
02/24/2021 |
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 Model Number | 75100476 |
Device Catalogue Number | 75100476 |
Device Lot Number | B2027-07-20 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/25/2020
|
Initial Date FDA Received | 12/22/2020 |
Supplement Dates Manufacturer Received | 02/18/2021
|
Supplement Dates FDA Received | 02/24/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|