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

Model Number 135-5114

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Osteolysis (2377)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

Biopoly learned from physician about osteolysis/bone resorption in one of his patients, and that he removed the biopoly implant.

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
• Type of Device: 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
• MDR Text Key: 313806389
• Report Number: 3008108789-2023-00002
• Device Sequence Number: 1
• Product Code: KWD
• UDI-Device Identifier: 00850012119388
• UDI-Public: (01)00850012119388(17)260520(10)2133827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female