Brand Name | DEPUY ASR XL |
Type of Device | FEMORAL IMPLANT, SIZE 47 |
Manufacturer (Section D) |
DEPUY ORTHOPEDICS, INC |
warsaw IN 46582 |
|
MDR Report Key | 4916153 |
MDR Text Key | 15840480 |
Report Number | 4916153 |
Device Sequence Number | 2 |
Product Code |
KWA
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
06/19/2015 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/15/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/01/2011 |
Device Catalogue Number | 9998-90-247 |
Device Lot Number | 2192251 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 06/11/2015 |
Event Location |
Hospital
|
Date Report to Manufacturer | 06/16/2015 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 63 YR |
|
|