Brand Name | UNITRAX MODULAR ENDO HEAD 44MM |
Type of Device | PROSTHESIS, HIP, HEMI-, FEMORAL, METAL |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
|
mahwah NJ 07430 |
|
Manufacturer Contact |
marisol
santiago
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 15459892 |
MDR Text Key | 300296096 |
Report Number | 0002249697-2022-01386 |
Device Sequence Number | 1 |
Product Code |
KWL
|
UDI-Device Identifier | 07613327032383 |
UDI-Public | 07613327032383 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K014226 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/20/2022 |
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 |
Health Professional
|
Device Model Number | 6942-5-044 |
Device Catalogue Number | 6942-5-044 |
Device Lot Number | E42Y5M |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/28/2022 |
Initial Date FDA Received | 09/20/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/18/2022 |
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) |
Required Intervention;
Hospitalization;
|
Patient Age | 91 YR |
Patient Sex | Female |
Patient Weight | 64 KG |