Brand Name | TAPERED SPACER ARTICUL/EZE -3 |
Type of Device | HEMI HIP IMPLANT : HIP FEMORAL AUGMENT |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kate
karberg
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
3035526892
|
|
MDR Report Key | 14307256 |
MDR Text Key | 290951266 |
Report Number | 1818910-2022-08317 |
Device Sequence Number | 1 |
Product Code |
LZY
|
UDI-Device Identifier | 10603295032663 |
UDI-Public | 10603295032663 |
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 | 1363-08-000 |
Device Catalogue Number | 136308000 |
Device Lot Number | JM1037 |
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 | 11/16/2021 |
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; MODULAR CATHCART BALL 42MM OD; SUMMIT BASIC CEMENTED SZ 5 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 77 YR |
Patient Sex | Female |
Patient Weight | 60 KG |