Brand Name | ATTUNE RP TIBIAL IMPACTOR |
Type of Device | KNEE INSTRUMENT/TRIAL |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 5153119 |
MDR Text Key | 28388486 |
Report Number | 1818910-2015-32777 |
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 |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
09/29/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/15/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 254401004 |
Device Lot Number | AU3650772 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/12/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/23/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/05/2014 |
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 |
Patient Age | 70 YR |