Brand Name | OMNI HIP SYSTEM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED |
Manufacturer (Section D) |
OMNI LIFE SCIECE, INC. |
480 paramount drive |
raynham MA 02767 |
|
MDR Report Key | 12579153 |
MDR Text Key | 282288166 |
Report Number | 1226188-2021-00125 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00841690102496 |
UDI-Public | 00841690102496 |
Combination Product (y/n) | N |
PMA/PMN Number | K041950 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
10/05/2021 |
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 Model Number | 130006 |
Device Catalogue Number | 130006 |
Device Lot Number | 38933 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/21/2021
|
Initial Date FDA Received | 10/05/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 83 YR |
|
|