Brand Name | UNKNOWN OXFORD UNICOMPARTMENTAL KNEE |
Type of Device | PROSTHESIS, KNEE |
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 | 5950505 |
MDR Text Key | 54703729 |
Report Number | 0001825034-2016-03592 |
Device Sequence Number | 1 |
Product Code |
NRA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PP010014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/16/2016 |
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 Model Number | N/A |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/16/2016 |
Initial Date FDA Received | 09/14/2016 |
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
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|