Brand Name | AR, SMALL SOCKET INSERT, 32MM NEUTRAL EPLUS |
Type of Device | PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER |
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 | 18576958 |
MDR Text Key | 333659463 |
Report Number | 1644408-2024-00022 |
Device Sequence Number | 1 |
Product Code |
KWZ
|
UDI-Device Identifier | 00190446257554 |
UDI-Public | 00190446257554 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K172351 |
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 |
01/24/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/24/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 509-02-032 |
Device Lot Number | 951W2173 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/30/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/16/2023 |
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 | 508-32-103 LOT: 864C5931.; 508-32-204 LOT: 769P2759.; 533-08-108 LOT: 926W1889. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 79 YR |
Patient Sex | Female |