Brand Name | ALUMINA C-TAPER HEAD 28MM/0 |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
carrigtwohill NA |
EI NA |
|
Manufacturer (Section G) |
STRYKER ORTHOPAEDICS-CORK |
ida industrial estate |
|
carrigtwohill NA |
EI
NA
|
|
Manufacturer Contact |
marisol
santiago
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 19070224 |
MDR Text Key | 339701887 |
Report Number | 0002249697-2024-00568 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 07613327101164 |
UDI-Public | 07613327101164 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K971409 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/09/2024 |
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 | 02/02/2019 |
Device Catalogue Number | 17-2800E |
Device Lot Number | 47115702 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/28/2024
|
Initial Date FDA Received | 04/09/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/27/2014 |
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 | 44 YR |
Patient Sex | Female |
Patient Weight | 100 KG |