Brand Name | EXETER V40(TM). FEM. STEM 44MM |
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-CORK |
ida industrial estate |
|
carrigtwohill NA |
|
Manufacturer Contact |
collin
neitzel
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 8526815 |
MDR Text Key | 142340578 |
Report Number | 0002249697-2019-01654 |
Device Sequence Number | 1 |
Product Code |
JDI
|
UDI-Device Identifier | 04546540153418 |
UDI-Public | 04546540153418 |
Combination Product (y/n) | N |
Reporter Country Code | GB |
PMA/PMN Number | K173499 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/18/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0580-3-422 |
Device Lot Number | G7558934 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/22/2019
|
Initial Date FDA Received | 04/18/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Other;
|