Brand Name | V40 COCR LFIT HEAD 44MM/+0 |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED |
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 |
sanjana
talathi
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 19122657 |
MDR Text Key | 340340096 |
Report Number | 0002249697-2024-00609 |
Device Sequence Number | 1 |
Product Code |
JDI
|
UDI-Device Identifier | 07613327032734 |
UDI-Public | 07613327032734 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061434 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
04/16/2024 |
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 |
Health Professional
|
Device Expiration Date | 03/31/2014 |
Device Catalogue Number | 6260-9-144 |
Device Lot Number | MHE11A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/26/2024
|
Initial Date FDA Received | 04/16/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/27/2009 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 2249697-05/07/2018-003R |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 73 YR |
Patient Sex | Male |