Brand Name | DEPUY ASR XL FEM IMP SIZE 46 |
Type of Device | HIP FEMORAL HEAD |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD. 8010379 |
st. anthony's rd |
leeds LS11 8 DT |
UK LS11 8 DT |
|
Manufacturer (Section G) |
DEPUY INTERNATIONAL LTD. 8010379 |
st. anthony's rd |
|
leeds LS11 8 DT |
UK
LS11 8 DT
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582
|
5743725905
|
|
MDR Report Key | 6980049 |
MDR Text Key | 90333131 |
Report Number | 1818910-2017-27528 |
Device Sequence Number | 1 |
Product Code |
KXA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Health Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/27/2017 |
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 | 06/12/2011 |
Device Catalogue Number | 999890146 |
Device Lot Number | 1970800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/27/2017
|
Initial Date FDA Received | 10/26/2017 |
Supplement Dates Manufacturer Received | 10/19/2017 03/09/2018 05/21/2018
|
Supplement Dates FDA Received | 11/06/2017 03/09/2018 05/23/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/26/2005 |
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-1749/1816-2011 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|