Brand Name | ATTUNE PS FB INSRT SZ 3 5MM |
Type of Device | KNEE TIBIAL BEARING/INSERT |
Manufacturer (Section D) |
1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
steve
dowell
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714918
|
|
MDR Report Key | 5260422 |
MDR Text Key | 32476575 |
Report Number | 1818910-2015-32677 |
Device Sequence Number | 1 |
Product Code |
JWH
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | PK111433 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/05/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2017 |
Device Catalogue Number | 151640305 |
Device Lot Number | 290799 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/10/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/05/2014 |
Initial Date FDA Received | 12/02/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/05/2012 |
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 |