Brand Name | ATTUNE RP PS ARTIC SUFR SZ8 |
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 | 6677151 |
MDR Text Key | 78700800 |
Report Number | 1818910-2017-20393 |
Device Sequence Number | 1 |
Product Code |
NJL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P830055 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
06/01/2017 |
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 | 254500548 |
Device Lot Number | MVMBSV730 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/01/2017
|
Initial Date FDA Received | 06/29/2017 |
Supplement Dates Manufacturer Received | 07/17/2017 11/14/2017 11/14/2017 11/16/2017
|
Supplement Dates FDA Received | 07/27/2017 11/14/2017 11/15/2017 12/11/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 75 YR |