MalfunctionKWD
BIOPOLY® LESSER TOE HEMIARTHROPLASTY IMPLANT
Received Oct 29, 2025
Report 3008108789-2025-00006 · MDR key 23417750
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
FROM THE DESCRIPTION, THAT THE IMPLANT STEM SEPARATED AT THE CAP INTERFACE. THE IMPLANT WAS IMPLANTED WITHOUT CEMENT.
Description of Event or Problem
A BIOPOLY DISTRIBUTOR NOTIFIED US OF A BIOPOLY® LESSER TOE HEMIARTHROPLASTY IMPLANT REVISION.