Brand Name | RESTORATION ADM X3 INS 28/54 |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC |
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 |
marisol
santiago
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 17303343 |
MDR Text Key | 318923259 |
Report Number | 0002249697-2023-00764 |
Device Sequence Number | 1 |
Product Code |
MEH
|
UDI-Device Identifier | 04546540639004 |
UDI-Public | 04546540639004 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093644 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/11/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/11/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2017 |
Device Model Number | 1236-2-854 |
Device Catalogue Number | 1236-2-854 |
Device Lot Number | 41788501 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/15/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/15/2012 |
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) |
Required Intervention;
Hospitalization;
|
Patient Age | 71 YR |
Patient Sex | Male |