FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 20297406
·
Received September 24, 2024
Report
- Report Number
- 1644408-2024-01466
- Event Type
- Injury
- Date Received
- September 24, 2024
- Date of Event
- August 27, 2024
- Report Date
- October 17, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- PHX
- UDI-DI
- 00888912144537
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SEE D3, D4 EXPPIRATION DATE, G1, H4, H11 COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2023-00432; 509-00-032, S808 - INFECTION, 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 INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1292318 | DJO SURGICAL | RSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXE-PLUS | PHX | ENCORE MEDICAL L.P. | 377P1878 | 00888912144537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention | 508-32-101 LOT: 862C4513 |