Brand Name | COMPR SRS MOD STEM - 8X100MM |
Type of Device | COMPREHENSIVE SRS MODULAR STEM WITH SCREW |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 18944788 |
MDR Text Key | 338186871 |
Report Number | 0001825034-2024-00726 |
Device Sequence Number | 1 |
Product Code |
KWT
|
UDI-Device Identifier | 00880304540484 |
UDI-Public | (01)00880304540484(17)290204(10)829710 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K223631 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/20/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/20/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 211236 |
Device Lot Number | 829710 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/28/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/04/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | NI |
Patient Sequence Number | 1 |
Treatment | SEE NARRATIVE IN H10 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Sex | Female |