Brand Name | G7 HI-WALL E1 LINER 36MM G |
Type of Device | PROSTHETIC, 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 | 12576629 |
MDR Text Key | 274741085 |
Report Number | 0001825034-2021-02759 |
Device Sequence Number | 1 |
Product Code |
PBI
|
UDI-Device Identifier | 00880304527126 |
UDI-Public | (01)00880304527126(17)200901(10)3640206 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K121874 |
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 |
01/11/2022 |
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 |
Health Professional
|
Device Expiration Date | 09/01/2020 |
Device Model Number | N/A |
Device Catalogue Number | 010000937 |
Device Lot Number | 3640206 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/16/2021
|
Initial Date FDA Received | 10/05/2021 |
Supplement Dates Manufacturer Received | 01/10/2022
|
Supplement Dates FDA Received | 01/11/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2015 |
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) |
Hospitalization;
Required Intervention;
|