Brand Name | ATTUNE IMPACTION HANDLE |
Type of Device | KNEE INSTRUMENT/TRIAL |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
steve
dowell
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714918
|
|
MDR Report Key | 4660509 |
MDR Text Key | 5729822 |
Report Number | 1818910-2015-17793 |
Device Sequence Number | 1 |
Product Code |
LXH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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,Followup |
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 Catalogue Number | 254401017 |
Device Lot Number | NW143591 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/03/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/16/2015 |
Initial Date FDA Received | 04/06/2015 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 04/07/2015 04/17/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/05/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |