Brand Name | ATTUNE PS FB INSRT SZ 5 6MM |
Type of Device | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
Manufacturer (Section D) |
DEPUY IRELAND 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7575472 |
MDR Text Key | 110293280 |
Report Number | 1818910-2018-61523 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295049937 |
UDI-Public | 10603295049937 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111433 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/10/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/06/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2022 |
Device Catalogue Number | 151640506 |
Device Lot Number | H61048 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/02/2018 |
Date Device Manufactured | 03/24/2017 |
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 | 79 YR |
|
|