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 |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 5153023 |
MDR Text Key | 28374132 |
Report Number | 1818910-2015-32766 |
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 |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Followup |
Report Date |
10/07/2015 |
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 | NW152956 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/12/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/15/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/09/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/08/2014 |
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 |
|
|