Brand Name | TM ANKLE TIBIAL BASE SIZE 4 |
Type of Device | PROSTHESIS, ANKLE |
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 | 10909127 |
MDR Text Key | 218497852 |
Report Number | 0001822565-2020-03873 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120906 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/08/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/26/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | 00450004400 |
Device Lot Number | 64199805 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 04/08/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/02/2018 |
Is the Device Single Use? |
No Answer Provided
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Invalid Data
|
Patient Treatment Data |
Date Received: 11/26/2020 Patient Sequence Number: 1 |
|
|