Brand Name | TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 9 |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
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 | 18852890 |
MDR Text Key | 337068790 |
Report Number | 1644408-2024-00247 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00888912078672 |
UDI-Public | 00888912078672 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130099 |
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 |
03/06/2024 |
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 | 425-97-009 |
Device Lot Number | 174R1456 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/09/2024
|
Initial Date FDA Received | 03/06/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/07/2023 |
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 | 400-03-321 LOT: 860B1218; 940-00-040 LOT: 149Z1107; 941-01-32D LOT: 592Z1130 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 56 YR |
Patient Sex | Female |