Brand Name | UNKNOWN OXFORD IMPLANTS |
Type of Device | PROSTHESIS, KNEE |
Manufacturer (Section D) |
BIOMET UK LTD. |
waterton industrial estates |
bridgend CF31 3XA |
UK CF31 3XA |
|
Manufacturer (Section G) |
BIOMET UK LTD. |
waterton industrial estates |
|
bridgend CF31 3XA |
UK
CF31 3XA
|
|
Manufacturer Contact |
sian
rogers
|
waterton industrial estates |
bridgend CF31 -3XA
|
UK
CF31 3XA
|
0441656655
|
|
MDR Report Key | 4036817 |
MDR Text Key | 4879564 |
Report Number | 3002806535-2014-00188 |
Device Sequence Number | 1 |
Product Code |
NRA
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | PP010014 |
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 |
Report Date |
07/30/2014 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/30/2014
|
Initial Date FDA Received | 08/26/2014 |
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
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|