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

Model Number 135-51XX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Biopoly did not receive explant for inspection.Existence of periprosthetic bone absorption was unexplained, and the lot of implants was confirmed as manufactured to specifications.Loss of fixation of the implant is a possible adverse effect listed in the instructions for use (ifu) document, and a considered risk in the risk management system for this implant.Many possible factors could lead to loss of implant function, including failure to follow instructions for use, damage to the implant during implantation, 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 Description

Biopoly learned from physician about osteolysis/bone resorption in one of his patients, and that he removed the biopoly implant.Physician thought that the area was infected as his patient had some postoperative wound complications, but all cultures were negative upon implant removal, and there were no signs of infection.Physician originally suspected infection or rapid polyethylene disease as a cause for peri-implant bone resorption; however, there was no sign of implant wear.

• 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: jacob alumbaugh ; 7136 gettysburg pike; fort wayne, IN 46804 ; 2609996135
• MDR Report Key: 16709848
• MDR Text Key: 312985841
• Report Number: 3008108789-2023-00001
• Device Sequence Number: 1
• Product Code: KWD
• 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: 12/15/2022

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
• Device Operator: Health Professional
• Device Model Number: 135-51XX
• Device Catalogue Number: 135-51XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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