Brand Name | DELTA CER HEAD 12/14 28MM +5 |
Type of Device | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic drive |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 10184600 |
MDR Text Key | 196100916 |
Report Number | 1818910-2020-14284 |
Device Sequence Number | 1 |
Product Code |
LZO
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K011533 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,HEALTH |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Type of Report
| Initial,Followup |
Report Date |
06/10/2020 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 06/23/2020 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | 1365-28-320 |
Device Catalogue Number | 136528320 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 07/23/2020 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|