Brand Name | V40 COCR LFIT HEAD 36MM/+5 |
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 |
diana
rogers
|
210 centennial avenue |
centennial park, elstree |
borehamwood WD6 3-SJ
|
UK
WD6 3SJ
|
2082386500
|
|
MDR Report Key | 15433443 |
MDR Text Key | 300026839 |
Report Number | 0002249697-2022-01351 |
Device Sequence Number | 1 |
Product Code |
JDI
|
UDI-Device Identifier | 07613327032314 |
UDI-Public | 07613327032314 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K022077 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/15/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/15/2022 |
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 Model Number | 6260-9-236 |
Device Catalogue Number | 6260-9-236 |
Device Lot Number | MHDK4H |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/22/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/31/2009 |
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 | 80 YR |
Patient Sex | Female |