Brand Name | J-FX BIPOL SHELL&28MMLINR/54MM |
Type of Device | MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
JJM (SUZHOU) LTD. 3006356043 |
no. 299, changyang street |
suzhou industrial park |
suzhou, jiangsu 21512 6 |
CH
215126
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7490042 |
MDR Text Key | 107600515 |
Report Number | 1818910-2018-58963 |
Device Sequence Number | 1 |
Product Code |
KWY
|
Combination Product (y/n) | N |
PMA/PMN Number | K980801 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
04/11/2018 |
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 | 856754 |
Device Lot Number | D16010728 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/30/2018 |
Initial Date Manufacturer Received |
04/11/2018 |
Initial Date FDA Received | 05/07/2018 |
Supplement Dates Manufacturer Received | 04/30/2018 09/30/2018
|
Supplement Dates FDA Received | 05/23/2018 10/01/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2016 |
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 |