Brand Name | PINN SECTOR W/GRIPTION 48MM |
Type of Device | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7315979 |
MDR Text Key | 101578610 |
Report Number | 1818910-2018-54567 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 10603295010289 |
UDI-Public | 10603295010289 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071784 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
02/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 121732048 |
Device Lot Number | 646867 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/06/2018 |
Initial Date FDA Received | 03/06/2018 |
Supplement Dates Manufacturer Received | 02/06/2018 03/21/2018 03/27/2018
|
Supplement Dates FDA Received | 03/07/2018 03/28/2018 04/16/2018
|
Date Device Manufactured | 04/15/2015 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |
Patient Weight | 78 |