Brand Name | ARTICULAR SURFACE PROVISIONAL SIZE EF 9 MM HEIGHT |
Type of Device | INSTRUMENT, KNEE |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
1800 w. center st. |
warsaw IN 46580 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
1800 w. center st. |
|
warsaw IN 46580 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 18747232 |
MDR Text Key | 335870352 |
Report Number | 0001822565-2024-00609 |
Device Sequence Number | 1 |
Product Code |
HWT
|
Combination Product (y/n) | N |
Reporter Country Code | JO |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/10/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00596103209 |
Device Lot Number | 62873035 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/29/2024 |
Initial Date FDA Received | 02/21/2024 |
Supplement Dates Manufacturer Received | 04/04/2024
|
Supplement Dates FDA Received | 04/10/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/15/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|