FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 19978346
·
Received August 13, 2024
Report
- Report Number
- 1644408-2024-01219
- Event Type
- Injury
- Date Received
- August 13, 2024
- Date of Event
- July 19, 2024
- Report Date
- August 13, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- FZX
- UDI-DI
- 00888912166737
- PMA / PMN Number
- K143242
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO:1644408-2018-00192; 241-02-109, S810 - DEVICE LOOSENING, S814 - STABILITY, POOR JOINT, 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 - PATIENT COMPLAINT OF PAIN/INSTABILITY. SURGEON TESTED FOR LAXITY OF JOINT. TIBIA COMPONENT FOUND TO BE LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220908 | DJO SURGICAL | EMPOWR 3D KNEETM FEMUR, NP, 6R | FZX | ENCORE MEDICAL L.P. | 950R1667T | 00888912166737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention | 130-03-735 LOT: 156N2228| 342-14-706 LOT: 140T1082| 351-02-106 LOT: 992R1263 |