Brand Name | NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 21 HOLES, 393 MM |
Type of Device | TRAUMA PROSTHESIS |
Manufacturer (Section D) |
ZIMMER SWITZERLAND MANUFACTURING GMBH |
sulzer allee 8 |
sulzer industrie park |
winterthur 8404 |
SZ 8404 |
|
Manufacturer (Section G) |
ZIMMER SWITZERLAND MANUFACTURING GMBH |
sulzer allee 8 |
sulzer industrie park |
winterthur 8404 |
SZ
8404
|
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 15367781 |
MDR Text Key | 299357651 |
Report Number | 0009613350-2022-00444 |
Device Sequence Number | 1 |
Product Code |
HRS
|
UDI-Device Identifier | 00889024297593 |
UDI-Public | (01)00889024297593 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K100111 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/19/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | N/A |
Device Catalogue Number | 0203264021 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/28/2022 |
Initial Date FDA Received | 09/07/2022 |
Supplement Dates Manufacturer Received | 10/06/2022
|
Supplement Dates FDA Received | 10/19/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 72 YR |
Patient Sex | Female |
Patient Weight | 99 KG |
|
|