BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT
Received Sep 12, 2025 · Event occurred Aug 13, 2025
Report 3008108789-2025-00005 · MDR key 23041579
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
FROM THE DESCRIPTION, IT APPEARS THAT THE IMPLANT WAS ARTICULATING AGAINST A NON-CARTILAGE SURFACE (I.E. PHALANGEAL OSTEOPHYTES, ROUGHENED OR EXPOSED BONE, OR BONE SPURS) AS WAS EVIDENT FROM WEAR THAT OCCURRED ON ONE EDGE OF THE IMPLANT. THIS TYPE OF ARTICULATION IS WARNED AGAINST IN THE IFU. THE ORIENTATION OF THE IMPLANT IS UNKNOWN; THEREFORE, IT IS IMPOSSIBLE TO DETERMINE WHICH PART OF THE PHALANX ARTICULATING SURFACE OR RIM (DORSAL OR PLANTAR) CAUSED THE WEAR. ALSO, OTHER CONTRIBUTING FACTORS TO THIS WEAR COULD BE A TIGHT JOINT AND/OR OVERSTUFFING. THESE FACTORS CAN SET UP A CONDITION WHERE THE PROXIMAL PHALANGEAL DORSAL OR PLANTAR RIM COULD DAMAGE THE ARTICULATING SURFACE. GROSS WEAR COULD LEAD TO OSTEOLYSIS, SIMILAR TO WHAT IS SEEN IN TOTAL JOINTS; HOWEVER, IT IS UNCLEAR IF THIS WAS THE CASE.
Description of Event or Problem
A BIOPOLY DISTRIBUTOR NOTIFIED US OF A BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT REVISION.