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); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Biopoly did not receive the explant for inspection.The sales representative did, however, provide an image of the explant.The device 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 cannot be confirmed, 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, 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 device.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, it will be reviewed for reportability and submitted for follow-up as appropriate.
Event or Problem Description
Biopoly learned from a sales representative about a revision surgery to remove a biopoly great toe implant after the patient presented osteolysis/bone resorption.

• Brand Name: BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
• Common Device Name: TOE PROSTHESIS
• Manufacturer (Section D): BIOPOLY LLC; 7136 gettyburg 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: 17895187
• Report Number: 3008108789-2023-00006
• Device Sequence Number: 7006764
• Product Code: KWD
• UDI-Device Identifier: 00850012119388
• UDI-Public: (01)00850012119388(17)260520(10)2133827
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/09/2023
• 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 Sex: Female