Brand Name | CERAMAX CERAMIC INSERT 28 X 48 |
Type of Device | HIP ACETABULAR LINER |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
steve
dowell
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743714918
|
|
MDR Report Key | 4114537 |
MDR Text Key | 12208240 |
Report Number | 1818910-2014-28765 |
Device Sequence Number | 1 |
Product Code |
MRA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PP070026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/24/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Catalogue Number | 121889648 |
Device Lot Number | 5355204 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/29/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/11/2015
|
Initial Date FDA Received | 09/24/2014 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 09/24/2014 10/01/2014 04/24/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/28/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 46 YR |
Patient Weight | 103 |