Brand Name | FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6 |
Type of Device | PROSTHESIS, HIP |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 14141006 |
MDR Text Key | 289500786 |
Report Number | 0001825034-2022-00922 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 00889024508798 |
UDI-Public | (01)00889024508798(17)260331(10)3066887 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K182048 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
07/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/19/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | N/A |
Device Catalogue Number | 574102060 |
Device Lot Number | 3066887 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/17/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/30/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |