Brand Name | MODULAR CATHCART BALL 42MM 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) |
JJM (SUZHOU) LTD. 3006356043 |
no.299 changyang st |
suzhou industrial park |
suzhou jiangsu 21512 -6 |
CH
21512-6
|
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14307281 |
MDR Text Key | 290920346 |
Report Number | 1818910-2022-08316 |
Device Sequence Number | 1 |
Product Code |
LZY
|
UDI-Device Identifier | 10603295032748 |
UDI-Public | 10603295032748 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K903084 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/06/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1363-42-000 |
Device Catalogue Number | 136342000 |
Device Lot Number | D21041840 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/19/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/19/2021 |
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 | CEMENTRALIZER 12.0; SUMMIT BASIC CEMENTED SZ 5; TAPERED SPACER ARTICUL/EZE -3 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 77 YR |
Patient Sex | Female |
Patient Weight | 60 KG |