Brand Name | TRIDENT 28 D CERAMIC LINER |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
|
carrigtwohill NA |
EI
NA
|
|
Manufacturer Contact |
brad
curtis
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 11113721 |
MDR Text Key | 225060143 |
Report Number | 0002249697-2021-00026 |
Device Sequence Number | 1 |
Product Code |
MRA
|
UDI-Device Identifier | 04546540516831 |
UDI-Public | 04546540516831 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P000013 |
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 |
01/04/2021 |
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 | 625-0T-28D |
Device Catalogue Number | 625-0T-28D |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/08/2020 |
Initial Date FDA Received | 01/04/2021 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 66 YR |
Patient Weight | 91 |