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

Model Number	135-5118
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561); Insufficient Information (4580)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A patient developed joint stiffness and pain and had the biopoly implant removed.

• Brand Name: BIOPOLY GREAT TOE HEMIARTHROPLASTY IMPLANT
• Common Device Name: 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
• Report Number: 3008108789-2023-00004
• Device Sequence Number: 6667124
• Product Code: KWD
• UDI-Device Identifier: 00850012119401
• UDI-Public: (01)00850012119401(17)260520(10)2133830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/26/2023
• 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