Brand Name | MODULAR CENTER POST REAMER |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
1800 w. center st. |
warsaw IN 46580 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
1800 w. center st. |
|
warsaw IN 46580 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 15846468 |
MDR Text Key | 306815427 |
Report Number | 0001822565-2022-03249 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K191814 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/16/2022 |
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 | SBGL3007 |
Device Lot Number | 65003639 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/14/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/31/2022 |
Initial Date FDA Received | 11/22/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/09/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | NI |
Patient Sequence Number | 1 |
Patient Sex | Prefer Not To Disclose |