BIOPOLY GREAT TOE HEMIARTHROPLASTY
Received Nov 7, 2024 · Event occurred Sep 1, 2024
Report 3008108789-2024-00001 · MDR key 20630731
Device
Generic name
Toe Prosthesis, Product Code: Kwd
Manufacturer
Biopoly, LlcModel number
135-51XXCatalog number
135-51XX
Lot number
N/A
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Inadequate Pain Relief
- Implant Pain
- Inadequate Pain Relief
- Implant Pain
Narrative
Description of Event or Problem
BIOPOLY RECEIVED NOTIFICATION FROM A PHYSICIAN REGARDING A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLAN AFTER THE PATIENT PRESENTED WITH PAIN.
Additional Manufacturer Narrative
BIOPOLY INTERVIEWED THE SURGEON'S DEVICE REP AND LEARNED THAT THE PATIENT PRESENTED PAIN AND HAD SOFT TISSUE SCARRING. THE IMPLANT SHOWED NO SIGN OF WEAR OR OTHER FAILURE AND WAS ATTACHED TO THE BONE ACCORDING TO THE SURGEON. THERE WAS NO INDICATION OF DEVICE FAILURE, BUT RATHER THE REASON FOR THE REVISION WAS LIKELY PATIENT SELECTION. IF ADDITIONAL INFORMATION IS RECEIVED, INFORMATION WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.