FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 20153756
·
Received September 5, 2024
Report
- Report Number
- 1644408-2024-01381
- Event Type
- Injury
- Date Received
- September 5, 2024
- Date of Event
- August 17, 2024
- Report Date
- September 5, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- LPH
- UDI-DI
- 00190446309529
- PMA / PMN Number
- K190057
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO:1644408-2020-01231; 941-01-32D, 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 |
|---|---|---|---|---|---|---|---|
| 2141297 | DJO SURGICAL | EMPOWR ACETABULAR SYSTEM, LINER, NEUTRAL, HXE+, 36F | LPH | ENCORE MEDICAL L.P. | 598Z1238 | 00190446309529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Male | Other | 400-03-362 LOT: 866B2143| 940-02-52F LOT: 800Z1327 |