Brand Name | NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA |
Type of Device | PROSTHESIS, 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 | 17699148 |
MDR Text Key | 322844112 |
Report Number | 0001822565-2023-02445 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 00889024309814 |
UDI-Public | (01)00889024309814(17)220930(10)63703536 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K172524 |
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 |
01/10/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/07/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2022 |
Device Model Number | N/A |
Device Catalogue Number | 00587806535 |
Device Lot Number | 63703536 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/10/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/12/2017 |
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 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Sex | Male |