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

Model Number 135-5118

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Implant Pain (4561); Insufficient Information (4580)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

Biopoly received the explant for inspection.The explant was examined under magnification, and there were no signs of visible wear.The osteosync material was securely attached to the stem.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.There were no concerns identified regarding the explant that may have led to the patient developing stiffness or pain.If additional information is received, information will be reviewed for reportability and submitted for follow-up as appropriate.

Event Description

A patient developed joint stiffness and pain and had the biopoly implant removed.

• Brand Name: BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
• Type of Device: TOE PROSTHESIS
• Manufacturer (Section D): BIOPOLY LLC; 7136 gettysburg pike; fort wayne, in 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: 17200186
• MDR Text Key: 317903121
• Report Number: 3008108789-2023-00004
• Device Sequence Number: 1
• Product Code: KWD
• UDI-Device Identifier: 00850012119401
• UDI-Public: (01)00850012119401(17)260520(10)2133830
• 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: 06/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 135-5118
• Device Catalogue Number: 135-5118
• Device Lot Number: 2133830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 06/26/2023
• 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 Sex: Female