Brand Name | PINNACLE 100 ACET CUP 58MM |
Type of Device | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg ringaskiddy |
|
cork |
EI
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7650326 |
MDR Text Key | 112724650 |
Report Number | 1818910-2018-63513 |
Device Sequence Number | 1 |
Product Code |
KWA
|
UDI-Device Identifier | 10603295008583 |
UDI-Public | 10603295008583 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K073504 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/01/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/29/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 121701058 |
Device Lot Number | 8470085 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/01/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/14/2017 |
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 | 67 YR |
Patient Weight | 99 |