Brand Name | TOTAL ASR FEM IMP SIZE 46 |
Type of Device | ASR HIP SYSTEM : HIP METAL FEMORAL HEADS |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD - 8010379 |
st. anthony's road |
leeds LS11 8DT |
UK
LS11 8DT |
|
Manufacturer (Section G) |
LEEDS MFG & MATERIAL WAREHOUSE |
st anthonys road |
|
leeds LS11 8DT |
UK
LS11 8DT
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 10283674 |
MDR Text Key | 199101653 |
Report Number | 1818910-2020-16059 |
Device Sequence Number | 1 |
Product Code |
KWA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
07/03/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/16/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Catalogue Number | 999803946 |
Device Lot Number | 2299815 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 07/27/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/11/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-1749/1816-2011 |