Brand Name | ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 42, E-PLUS |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
|
austin TX 78758 5445 |
|
Manufacturer Contact |
james
mcmahon
|
9800 metric blvd |
austin, TX 78758-5445
|
|
MDR Report Key | 17992843 |
MDR Text Key | 326349227 |
Report Number | 1644408-2023-01463 |
Device Sequence Number | 1 |
Product Code |
PAO
|
UDI-Device Identifier | 00190446178361 |
UDI-Public | 00190446178361 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162024 |
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 |
10/18/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/23/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 521-07-242 |
Device Lot Number | 891U1037 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/21/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | 520-00-000 , LOT 878C1761; 520-01-010 , LOT 455G1265; 520-46-116 , LOT 923C1132 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Sex | Female |
|
|