Brand Name | COMPREHENSIVE - LG HYBRID GLENOID BASE |
Type of Device | PROSTHESIS, SHOULDER |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
MDR Report Key | 8647934 |
MDR Text Key | 146333923 |
Report Number | 0001825034-2019-02344 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
PMA/PMN Number | K060694 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
10/15/2019 |
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 Expiration Date | 12/28/2013 |
Device Model Number | N/A |
Device Catalogue Number | 113956 |
Device Lot Number | 688380 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/02/2019 |
Initial Date FDA Received | 05/28/2019 |
Supplement Dates Manufacturer Received | 09/17/2019
|
Supplement Dates FDA Received | 10/15/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | 113063, HEAD, 399380; 113633, STEM, 795580; 118001, TAPER, 221400; PT-113950,GLENOID POST, 981930; UNKNOWN COBALT BONE CEMENT |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 76 YR |
Patient Weight | 84 |
|
|