Brand Name | HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100MM |
Type of Device | PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 9215371 |
MDR Text Key | 163123673 |
Report Number | 0001822565-2019-04500 |
Device Sequence Number | 1 |
Product Code |
JDC
|
UDI-Device Identifier | 00889024271340 |
UDI-Public | 00889024271340 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K123862 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/03/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00840004410 |
Device Lot Number | 63313336 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/13/2019 |
Initial Date FDA Received | 10/21/2019 |
Supplement Dates Manufacturer Received | 03/30/2020 05/02/2022
|
Supplement Dates FDA Received | 03/31/2020 05/04/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/18/2016 |
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 |
Treatment | 00840002407 ULNAR COMPONENT LOT # 63480682; 00840009000 HUMERAL SCREW KIT LOT # 63610436; 00840009400 ARTICULATION KIT LOT # 63419001 |
Patient Outcome(s) |
Other;
|
Patient Age | 59 YR |
Patient Sex | Female |
Patient Weight | 52 KG |