Brand Name | ARCOS 30X250MM SPL TPR DIST |
Type of Device | PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
MDR Report Key | 8676179 |
MDR Text Key | 147256069 |
Report Number | 0001825034-2019-02443 |
Device Sequence Number | 1 |
Product Code |
KWA
|
Combination Product (y/n) | N |
PMA/PMN Number | K090757 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
10/04/2019 |
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 |
Health Professional
|
Device Catalogue Number | 11-301030 |
Device Lot Number | 951070 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/31/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/31/2019 |
Initial Date FDA Received | 06/06/2019 |
Supplement Dates Manufacturer Received | 09/30/2019
|
Supplement Dates FDA Received | 10/04/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|