Brand Name | G7 NEUTRAL E1 LINER 32MM D |
Type of Device | PROSTHESIS, HIP |
Manufacturer (Section D) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
megan
haas
|
56 e. bell drive |
warsaw, IN 46582
|
5743726700
|
|
MDR Report Key | 5845262 |
MDR Text Key | 51109963 |
Report Number | 0001825034-2016-02870 |
Device Sequence Number | 1 |
Product Code |
PBI
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | PK121874 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
06/30/2017 |
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 |
Physician
|
Device Expiration Date | 07/22/2020 |
Device Model Number | N/A |
Device Catalogue Number | 010000848 |
Device Lot Number | 3616174 |
Other Device ID Number | SEE NARRATIVE IN H10 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/11/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/06/2016
|
Initial Date FDA Received | 08/03/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided 01/23/2017
|
Supplement Dates FDA Received | 09/08/2016 11/21/2016 01/30/2017 07/05/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/24/2015 |
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;
|