BioPoly® Great Toe Hemiarthroplasty Implant 135-5118Recalls & reported problems
Biopoly, LLC · BioPoly® Great Toe Hemiarthroplasty Implant - 18mm Porous · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850012119401), received between Jun 26, 2023 and May 22, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use2
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
- Insufficient Information1
- Osteolysis1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2024Off-Label Use; Off-Label Use
BIOPOLY LEARNED FROM A PHYSICIAN ABOUT A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT AFTER THE PATIENT PRESENTED WITH PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 19369957 ↗MalfunctionJul 11, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem
BIOPOLY LEARNED FROM PHYSICIAN ABOUT OSTEOLYSIS/BONE RESORPTION IN ONE OF HIS PATIENTS, AND HE REMOVED THE BIOPOLY IMPLANT.
Patient problems: Osteolysis
MAUDE report 17299738 ↗InjuryJun 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A PATIENT DEVELOPED JOINT STIFFNESS AND PAIN AND HAD THE BIOPOLY IMPLANT REMOVED.
Patient problems: Implant Pain; Insufficient Information; Pain
MAUDE report 17200186 ↗
Other Prosthesis, Toe, Hemi-, Phalangeal devices
- TOE JOINT TITANIUM NPC LG 23MM 16816Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC M/L 21.5MM 16815Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC MD 20MM 16814Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC MD 20MM 17036Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC SM 17MM 16813Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC M/S 18.5MM 17197Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC SM 17MM 17035Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- BioPoly® Great Toe Hemiarthroplasty Implant 135-5114Biopoly, LLC · Prosthesis, Toe, Hemi-, Phalangeal2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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