FDA Adverse Event
Injury
Summary report: N
EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 40G
MDR report key: 18727831
·
Received February 16, 2024
Report
- Report Number
- 1644408-2024-00149
- Event Type
- Injury
- Date Received
- February 16, 2024
- Date of Event
- January 22, 2024
- Report Date
- February 16, 2024
- Manufacturer
- ENCORE MEDICAL L.P
- Product Code
- PLH
- UDI-DI
- 00190446309581
- PMA / PMN Number
- K190057
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO PREVIOUS REPORT NUMBER 1644408-2022-01265; 941-01-40G, S808 - INFECTION, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Description of Event or Problem · 0
REVISION SURGERY - DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1085639 | EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 40G | ORTHODONTIC LED ACCESSORY | PLH | ENCORE MEDICAL L.P | 604Z1147 | 00190446309581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention | 400-03-403 LOT:873B1278| 450-01-105 LOT: 542C1088 |