Brand Name | FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH |
Type of Device | PROSTHESIS, HIPS |
Manufacturer (Section D) |
ZIMMER MANUFACTURING B.V. |
turpeaux industrial park |
route #1 km 123.4 bldg #1 |
mercedita PR 00715 |
|
Manufacturer (Section G) |
ZIMMER MANUFACTURING B.V. |
turpeaux industrial park |
route #1 km 123.4 bldg #1 |
mercedita PR 00715 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 19060307 |
MDR Text Key | 339602305 |
Report Number | 0002648920-2024-00098 |
Device Sequence Number | 1 |
Product Code |
JDI
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K191735 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/08/2024 |
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 |
Lay User/Patient
|
Device Model Number | N/A |
Device Catalogue Number | 00811400100 |
Device Lot Number | 64768871 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/19/2024
|
Initial Date FDA Received | 04/08/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/08/2020 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 87 YR |
Patient Sex | Female |