Brand Name | UNKNOWN_ABG II STEM |
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 |
NA
|
|
Manufacturer Contact |
alessandra
chavez
|
2555 davie road |
fort lauderdale, FL 33317
|
9546280700
|
|
MDR Report Key | 10127259 |
MDR Text Key | 194322070 |
Report Number | 0002249697-2020-01066 |
Device Sequence Number | 1 |
Product Code |
MEH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Reporter Occupation |
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
06/17/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/08/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Catalogue Number | UNK_SHC |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 05/29/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-2089-2012 |
Patient Treatment Data |
Date Received: 06/08/2020 Patient Sequence Number: 1 |
|
|