Brand Name | ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, L |
Type of Device | ANATOMICA GLENOID COMPONENT |
Manufacturer (Section D) |
ZIMMER GMBH |
sulzer allee 8 |
sulzer industrie park |
winterthur 8404 |
SZ 8404 |
|
MDR Report Key | 7493500 |
MDR Text Key | 107563780 |
Report Number | 0009613350-2018-00496 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
PMA/PMN Number | PK990136 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Type of Report
| Initial,Followup |
Report Date |
10/02/2018 |
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 |
Lay User/Patient
|
Device Expiration Date | 09/30/2020 |
Device Model Number | N/A |
Device Catalogue Number | 01.04214.400 |
Device Lot Number | 2677693 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/09/2018
|
Initial Date FDA Received | 05/08/2018 |
Supplement Dates Manufacturer Received | 09/28/2018
|
Supplement Dates FDA Received | 10/02/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | SIDUS ANCHOR, ITEM# 01.04555.130, LOT# 2830084; SIDUS HEAD, ITEM# 01.04555.520, LOT# 2829244; SIDUS ANCHOR, ITEM# 01.04555.130, LOT# 2830084; SIDUS HEAD, ITEM# 01.04555.520, LOT# 2829244 |
Patient Outcome(s) |
Other;
|
Patient Age | 58 YR |
Patient Weight | 120 |
|
|