MAUDE Adverse Event Report: BIOPOLY LLC BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT; TOE PROSTHESIS

Model Number	135-5118
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant manufacturing lot met all specifications.Biopoly interviewed the surgeon, and learned that the implant was used in a patient with grade iv hallux rigidus, and the implant was likely articulating with a non-cartilage surface.This is warned against in the ifu, as articulating with rough surfaces may lead to excessive and abrasive wear and eventually lead to osteolysis.Wear and damage of the implant are possible adverse effects listed in the instructions for use (ifu) document and considered risks in the risk management system for the implant.Many possible factors could lead to damage to the implant during implantation, including failure to follow instructions for use, use of implant against non-cartilage surface, or improper patient selection (age, bone quality, cartilage health).If additional information is received, information will be reviewed for reportability and submitted for follow-up as appropriate.
Event or Problem Description
Biopoly learned from a physician about a revision surgery to remove a biopoly great toe implant after the patient presented with pain.

• Brand Name: BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
• Common Device Name: TOE PROSTHESIS
• Manufacturer (Section D): BIOPOLY LLC; 7136 gettysburg pike; fort wayne IN 46804
• Manufacturer (Section G): BIOPOLY LLC; 7136 gettysburg pike; fort wayne IN 46804
• Manufacturer Contact: herb schwartz ; 7136 gettysburg pike; fort wayne, IN 46804 ; 2609996135
• MDR Report Key: 19369957
• Report Number: 3008108789-2024-00003
• Device Sequence Number: 18047038
• Product Code: KWD
• UDI-Device Identifier: 00850012119401
• UDI-Public: (01)00850012119401(17)260520(10)2133830
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2026
• Device Model Number: 135-5118
• Device Catalogue Number: 135-5118
• Device Lot Number: 2133830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male