Brand Name | ATTUNE FB TIB BASE SZ 6 CEM |
Type of Device | ATTUNE IMPLANT : KNEE TIBIAL TRAY |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
CORK MFG & MATERIAL WAREHOUSE |
loughbeg ringaskiddy |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, IN 46581-0988
|
6103142063
|
|
MDR Report Key | 9167522 |
MDR Text Key | 161605540 |
Report Number | 1818910-2019-108368 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295042402 |
UDI-Public | 10603295042402 |
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K101433 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/17/2019 |
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 |
Health Professional
|
Device Catalogue Number | 150600006 |
Device Lot Number | 8298107 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/17/2019 |
Initial Date FDA Received | 10/08/2019 |
Supplement Dates Manufacturer Received | 12/03/2019
|
Supplement Dates FDA Received | 12/04/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/03/2016 |
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 |
Treatment | ATTUNE PS FB INSRT SZ 7 7MM; ATTUNE PS FEM LT SZ 7 CEM |
Patient Outcome(s) |
Required Intervention;
|
Patient Weight | 100 |