Brand Name | MODULAR CATHCART BALL 46MM OD |
Type of Device | HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
JJMSZ PLANT FOR STK. & N-STK. |
no. 299, changyang street |
suzhou industrial park |
suzhou, jiangsu 21512 6 |
CH
215126
|
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380-0988
|
6103142063
|
|
MDR Report Key | 9342708 |
MDR Text Key | 167017880 |
Report Number | 1818910-2019-116956 |
Device Sequence Number | 1 |
Product Code |
LZY
|
UDI-Device Identifier | 10603295032786 |
UDI-Public | 10603295032786 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/22/2019 |
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 | 136346000 |
Device Lot Number | D18052468 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/22/2019 |
Initial Date FDA Received | 11/19/2019 |
Supplement Dates Manufacturer Received | 12/09/2019
|
Supplement Dates FDA Received | 12/16/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/30/2018 |
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 |
Treatment | CEMENT BONE FULL DOSE 40G SIMPLEX SPEEDSET P; CEMENT BONE FULL DOSE 40G SIMPLEX SPEEDSET P |
Patient Outcome(s) |
Required Intervention;
|