Brand Name | RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXE-PLUS |
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 | 18422518 |
MDR Text Key | 331665440 |
Report Number | 1644408-2023-01888 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 00888912144544 |
UDI-Public | 00888912144544 |
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 |
12/29/2023 |
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 | 509-00-036 |
Device Lot Number | 378P1462A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/04/2023
|
Initial Date FDA Received | 12/29/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/04/2022 |
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: 831C2202; 506-03-118 LOT: 832C2020; 506-03-118 LOT: 832C2024; 506-03-130 LOT: 835C1995; 508-32-204 LOT:769P2473; 508-36-101 LOT: 869C3636; 530-12-048 LOT: 1486A1073 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 64 YR |
Patient Sex | Male |