InjuryKWI
BIOPOLY® RADIAL HEAD IMPLANT
Received Apr 22, 2026 · Event occurred Mar 11, 2026
Report 3008108789-2026-00002 · MDR key 24957800
Device
Generic name
Prosthesis, Radial Head, Product Code: Kwi
Manufacturer
Biopoly LlcModel number
160-50X0Catalog number
160-50X0
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A REVISION OF THE BIOPOLY RADIAL HEAD IMPLANT WAS REPORTED. THE DEVICE WAS INITIALLY MIS-ALIGNED AND SURGICAL INTERVENTION WAS REQUIRED TO IMPLANT A NEW DEVICE WITH THE PROPER ALIGNMENT. NO WEAR OR DAMAGE TO THE INITIAL IMPLANT WAS OBSERVED.
Description of Event or Problem
A BIOPOLY DISTRIBUTOR NOTIFED US OF A BIOPOLY® RADIAL HEAD IMPLANT REVISION.