FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER INSIGNIA HIP
MDR report key: 24678472
·
Received March 24, 2026
Report
- Report Number
- 0002249697-2026-00227
- Event Type
- Injury
- Date Received
- March 24, 2026
- Date of Event
- February 26, 2026
- Report Date
- March 23, 2026
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE FOLLOWING INFORMATION WAS PROVIDED: INSIGNIA STUDY. PER REVIEW OF MILESTONE REPORT, SUBJECT EXPERIENCED SINGLE STAGE REVISION FOR PJI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741962 | UNKNOWN STRYKER INSIGNIA HIP | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |