BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
Received Nov 7, 2024 · Event occurred Oct 1, 2024
Report 3008108789-2024-00002 · MDR key 20630771
Device
Generic name
Toe Prosthesis
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
Additional Manufacturer Narrative
BIOPOLY RECEIVED NOTIFICATION FROM A PHYSICIAN REGARDING A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT. PRIOR TO EXPLANATION, BIOPOLY REQUESTED ADDITIONAL INFORMATION, AND THE SURGEON INDICATED THAT THE PATIENT HAD BEEN IMPLANTED ABOUT 4 MONTHS PRIOR. THIS PATIENT HAD BEEN EXPERIENCING PAIN AND SWELLING ALMOST THE ENTIRETY OF THEIR TIME SINCE IMPLANTATION. EITHER THE PATIENT WAS JUST NOT A GOOD CANDIDATE FOR THE IMPLANT OR THE JOINT WAS TOO TIGHT OR TOO RIGID. THIS DOES NOT APPEAR TO BE AN IMPLANT RELATED ISSUE. THE EXPLANT WAS NOT RETURNED. IF ADDITIONAL INFORMATION IS RECIEVED, INFORMATION WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED FOR FOLLOW-UP AS APPROPRIATE.
Description of Event or Problem
BIOPOLY RECEIVED NOTIFICATION FROM A PHYSICIAN REGARDING A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT.