FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 21839662
·
Received April 15, 2025
Report
- Report Number
- 1644408-2025-00428
- Event Type
- Injury
- Date Received
- April 15, 2025
- Date of Event
- March 21, 2025
- Report Date
- April 14, 2025
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- KWS
- PMA / PMN Number
- K112069
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-00382; (B)(4), (B)(4) - STABILITY, POOR JOINT, REVISION SURGERY; SURGICAL - QUALITY COMPLAINTS. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. KL (B)(6) 2025
Description of Event or Problem · 0
REVISION SURGERY - DUE TO INSTABILITY. KL(B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121984 | DJO SURGICAL | RSP BASEPLATE, 30MM, W/P2 COATING | KWS | ENCORE MEDICAL L.P. | 769P3520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention | 506-03-114 LOT: 831C2648| 506-03-118 LOT: 832C2431| 506-03-130 LOT: 835C2380| 506-03-130 LOT: 835C2383| 508-32-101 LOT: 862C4529| 509-01-432 LOT: 389P1220A| 530-14-108 LOT: 415T1494 |