Brand Name | ATTUNE FB TIB BASE SZ 5 CEM |
Type of Device | KNEE TIBIAL TRAY |
Manufacturer (Section D) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
cork, munster |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork, munster |
EI
|
|
Manufacturer Contact |
steve
dowell
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714918
|
|
MDR Report Key | 4276372 |
MDR Text Key | 5005170 |
Report Number | 1818910-2014-32599 |
Device Sequence Number | 1 |
Product Code |
JWH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK101433 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/30/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/25/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2023 |
Device Catalogue Number | 150600005 |
Device Lot Number | 7822388 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/03/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/08/2013 |
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;
|
Patient Age | 68 YR |
Patient Weight | 60 |
|
|