Brand Name | ENDURON 10D 60 OR 72ODX28ID |
Type of Device | HIP ACETABULAR INSERT/LINER |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46581
|
5743725905
|
|
MDR Report Key | 6015341 |
MDR Text Key | 56915532 |
Report Number | 1818910-2016-29087 |
Device Sequence Number | 1 |
Product Code |
HRY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K944538 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/04/2016 |
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 Catalogue Number | 124160025 |
Device Lot Number | R49A41027 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/04/2016
|
Initial Date FDA Received | 10/10/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 10/14/2016 11/30/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/22/1997 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 59 YR |
Patient Weight | 88 |