Brand Name | FMP HIP |
Type of Device | FMP HEMISPHERICAL SHELLS W/SCREW HOLES,52MM, W/P2 COATING |
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 | 14408430 |
MDR Text Key | 291729230 |
Report Number | 1644408-2022-00652 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 00888912084024 |
UDI-Public | (01)00888912084024 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K974093 |
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,Followup,Followup |
Report Date |
06/24/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/16/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 010-55-025 |
Device Catalogue Number | 430-98-052 |
Device Lot Number | 587G1468 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 06/22/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/23/2019 |
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 | 010-55-025 LOT 006A1541; 400-03-362 LOT 866B1827; 400-03-362 LOT 866B1827; 430-98-052 LOT 587G1468; 932-36-752 LOT 813N2041; 932-36-752 LOT 813N2041 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Sex | Female |