Brand Name | BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM |
Type of Device | SHOULDER PROSTHESIS, REVERSE CONFIGURATION |
Manufacturer (Section D) |
ENCORE MEDICAL L.P |
9800 metric blvd |
austin TX 78758 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P |
9800 metric blvd |
|
austin TX 78758 |
|
Manufacturer Contact |
james
mcmahon
|
9800 metric blvd |
austin, TX 78758
|
|
MDR Report Key | 18882647 |
MDR Text Key | 337401960 |
Report Number | 1644408-2024-00303 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 00888912024754 |
UDI-Public | 00888912024754 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K051075 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/11/2024 |
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 Catalogue Number | 508-32-104 |
Device Lot Number | 866C2943 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/11/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/28/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 506-03-114 LOT: 831C2021; 506-03-114 LOT: 831C2022; 506-03-122 LOT: 833C1770; 506-03-130 LOT: 835C1854; 508-32-101 LOT: 862C3537; 509-00-432 LOT: 385P1260 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |