Brand Name | COMPREHENSIVE INSTRUMENTATION METAL IMPACTOR |
Type of Device | SHOULDER PROSTHESIS, REVERSE CONFIGURATION |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 19000538 |
MDR Text Key | 338912925 |
Report Number | 0001825034-2024-00883 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 00887868470103 |
UDI-Public | (01)00887868470103(10)65699364 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K193373 |
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 |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 110029132 |
Device Lot Number | 65699364 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/20/2024 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/08/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/12/2022 |
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 | Female |