MalfunctionKWD
BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT
Received Nov 21, 2025 · Event occurred Oct 23, 2025
Report 3008108789-2025-00007 · MDR key 23620746
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
A REVISION OF A BIOPOLY GREAT TOE IMPLANT WAS REPORTED. THE PATIENT HAD COMPLAINED OF PAIN AND SWELLING. THE IMPLANT WAS WELL FIXED. THE SURGEON SPECULATED THAT THE PAIN AND SWELLING WAS A POSSIBLE RESULT OF AN ALLERGIC REACTION TO AN IMPLANT COMPONENT.
Description of Event or Problem
A BIOPOLY DISTRIBUTOR NOTIFIED US OF A BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT REVISION.