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

Model Number	135-5114
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Biopoly learned from physician about osteolysis/bone resorption in one of his patients, and that he removed the biopoly implant.
Additional Manufacturer Narrative
Biopoly received the explant for inspection.The explant was examined under magnification and appeared to show signs of abrasive wear.The remaining biopoly material was securely attached to the titanium stem and the osteosync material was also securely attached.The implant had been secured in the bone via press fit; however, there was no evidence that bone cement had been used.The implant manufacturing lot met all specifications.Although it is not confirmable, the cause appears to have been overstuffing of the joint along with the phalanx being devoid of cartilage, a contraindication, leading to excessive and abrasive biopoly wear and leading 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 this 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.

• 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: stone miguel ; 7136 gettysburg pike; fort wayne, IN 46804 ; 2609996135
• MDR Report Key: 16794259
• Report Number: 3008108789-2023-00002
• Device Sequence Number: 20555117
• Product Code: KWD
• UDI-Device Identifier: 00850012119388
• UDI-Public: (01)00850012119388(17)260520(10)2133827
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 04/24/2023

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: 135-5114
• Device Catalogue Number: 135-5114
• Device Lot Number: 2133827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 49 YR
• Patient Sex: Female