Brand Name | UNKNOWN NN, TRIDENT III |
Type of Device | HIP IMPLANT |
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 |
sharon
rivas
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 8203900 |
MDR Text Key | 131701618 |
Report Number | 0002249697-2018-04160 |
Device Sequence Number | 1 |
Product Code |
JDG
|
Combination Product (y/n) | N |
Reporter Country Code | SE |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/28/2018 |
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 | UNK_SHC |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/29/2018 |
Initial Date FDA Received | 12/28/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|