FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 20113560
·
Received August 30, 2024
Report
- Report Number
- 1644408-2024-01292
- Event Type
- Injury
- Date Received
- August 30, 2024
- Date of Event
- August 1, 2024
- Report Date
- October 3, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- KWS
- PMA / PMN Number
- K112069
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2023-00098; 508-32-204, S810 - DEVICE LOOSENING, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Additional Manufacturer Narrative · 0
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Description of Event or Problem · 0
REVISION SURGERY - DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1054805 | DJO SURGICAL | RSP BASEPLATE, 30MM, W/P2 COATING | KWS | ENCORE MEDICAL L.P. | 769P3287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Required Intervention | 506-03-114 LOT: 831C2607| 506-03-114 LOT: 831C2611| 506-03-122 LOT: 833C2225| 506-03-126 LOT: 834C2375| 508-32-103 LOT: 864C6822| 509-02-032 LOT: 951W2302| 533-08-000 LOT: 004Y1299 |