Brand Name | POLARSTEM COLLAR REAMER GUIDE |
Type of Device | PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
baar 06340 |
SZ 06340 |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
|
aarau CH500 0 |
SZ
CH5000
|
|
Manufacturer Contact |
sarah
freestone
|
oberneuhofstrasse 10d |
baar 06340
|
SZ
06340
|
0447940038
|
|
MDR Report Key | 10180009 |
MDR Text Key | 195961942 |
Report Number | 9613369-2020-00121 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 00885556535493 |
UDI-Public | (01)00885556535493(10)A57539 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143739 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/15/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/22/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 75102205 |
Device Catalogue Number | 75102205 |
Device Lot Number | A57539 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/14/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | Z-2827-2020 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|