FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 21270254
·
Received January 29, 2025
Report
- Report Number
- 1644408-2025-00075
- Event Type
- Injury
- Date Received
- January 29, 2025
- Date of Event
- January 13, 2025
- Report Date
- January 29, 2025
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- LPH
- UDI-DI
- 00888912084024
- PMA / PMN Number
- K974093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-00714; 520-56-222, 430-98-052, S807 - PAIN, 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 PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621268 | DJO SURGICAL | FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 52MM, W/P2 COATING | LPH | ENCORE MEDICAL L.P. | 587G1012 | 00888912084024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention | 400-03-361 LOT: 864B1040| 932-36-252 LOT: 728F1054 |