Brand Name | COMPR 10MM HUM FRACT STEM PPS |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
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 | 14346017 |
MDR Text Key | 291291002 |
Report Number | 0001825034-2022-01180 |
Device Sequence Number | 1 |
Product Code |
MBF
|
UDI-Device Identifier | 00880304591554 |
UDI-Public | (01)00880304591554(17)290516(10)438080 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K193038 |
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 |
Report Date |
06/28/2022 |
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 Model Number | N/A |
Device Catalogue Number | 12-113560 |
Device Lot Number | 438080 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/12/2022 |
Initial Date FDA Received | 05/10/2022 |
Supplement Dates Manufacturer Received | 05/31/2022
|
Supplement Dates FDA Received | 06/29/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/16/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Sex | Female |