Brand Name | ATTUNE FB TIB BASE SZ 8 CEM |
Type of Device | ATTUNE IMPLANT : KNEE TIBIAL TRAY |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
loughbeg ringaskiddy co. |
cork
|
EI
|
6103142063
|
|
MDR Report Key | 8266433 |
MDR Text Key | 133698143 |
Report Number | 1818910-2019-81686 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295042426 |
UDI-Public | 10603295042426 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101433 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/22/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 150600008 |
Device Lot Number | 7909558 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/28/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/26/2014 |
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 | 66 YR |