Brand Name | PROFEMUR® MODULAR FEMORAL NECK |
Type of Device | HIP COMPONENT |
Manufacturer (Section D) |
MICROPORT ORTHOPEDICS INC. |
5677 airline rd. |
arlington TN 38002 |
|
Manufacturer Contact |
rachael
wise
|
5677 airline road |
arlington, TN 38002
|
9018674771
|
|
MDR Report Key | 17987080 |
MDR Text Key | 326295713 |
Report Number | 3010536692-2023-00192 |
Device Sequence Number | 1 |
Product Code |
LWJ
|
UDI-Device Identifier | M684PHA012541 |
UDI-Public | M684PHA012541 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
12/19/2023 |
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 |
Other
|
Device Model Number | PHA01254 |
Device Catalogue Number | PHA01254 |
Device Lot Number | U11116210 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/28/2023
|
Initial Date FDA Received | 10/23/2023 |
Supplement Dates Manufacturer Received | 09/28/2023
|
Supplement Dates FDA Received | 12/19/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Removal/Correction Number | Z-2941-2020 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Male |
|
|