Brand Name | ASR ACETABULAR IMPLANT 64 |
Type of Device | ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS |
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 46582-0988
|
5743725905
|
|
MDR Report Key | 7872128 |
MDR Text Key | 120099833 |
Report Number | 1818910-2018-69215 |
Device Sequence Number | 1 |
Product Code |
KWA
|
Combination Product (y/n) | N |
Reporter Country Code | EI |
PMA/PMN Number | K040627 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
08/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/13/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 999805764 |
Device Lot Number | 1875715 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/13/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/31/2006 |
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) |
Death;
Required Intervention;
|