FDA Adverse Event
Injury
Summary report: N
RHEAD; RHEAD RADIAL HEAD IMPLANT
MDR report key: 3874026
·
Received June 5, 2014
Report
- Report Number
- 3003640913-2014-00043
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- November 19, 2013
- Report Date
- August 30, 2013
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- KWI
- PMA / PMN Number
- K011819
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL REMOVED COMPONENTS: MODEL#: RHA-S2. SURGERY REPORT AND PATIENT FILMS WERE REVIEWED AND INDICATE THAT THE IMPLANT LOOSENING WAS DUE TO IMPROPER SIZING AT PRIMARY SURGERY.
Description of Event or Problem · 1
THE RHEAD RADIAL HEAD IMPLANT FROM THE UNI-ELBOW RADIO CAPITELLUM SYSTEM WAS REVISED TO ADDRESS THE RADIAL HEAD LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328839 | RHEAD; RHEAD RADIAL HEAD IMPLANT | PROSTHESIS,ELBOW,HEMI,RADIAL,POLYMER | KWI | SMALL BONE INNOVATIONS, INC. | 410-0006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |