FDA Adverse Event
Injury
Summary report: N
STRYKER ORTHOPAEDICS
MDR report key: 14621151
·
Received May 23, 2022
Report
- Report Number
- 14621151
- Event Type
- Injury
- Date Received
- May 23, 2022
- Date of Event
- April 7, 2022
- Report Date
- May 20, 2022
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- HTO
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING A HIP REPLACEMENT PROCEDURE, A STRYKER REAMER BECAME LODGED IN THE PT'S FEMORAL CANAL. AN OSTEOTOMY WAS PERFORMED TO DISLODGE THE REAMER AND PREVENT FURTHER INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578936 | STRYKER ORTHOPAEDICS | REAMER 24MM | HTO | STRYKER ORTHOPAEDICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Male | Required Intervention |