MAUDE Adverse Event Report: IMPLANTCAST GMBH MUTARS®; CUSTOM MADE MUTARS® MK EPORE® PROX TIBIA SMALL TIN

Model Number SA1826402

Device Problems Fracture (1260); Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

The concerned devices are part of two compassionate use requests and therefore a "compassionate use device".The approval no.'s for these cases are # (b)(4) & (b)(4).The approval letters provide the following information concerning the medical history of the patient: "the patient, b.S., is a (b)(6) female with a history of osteosarcoma.She underwent a limb salvage procedure using a proximal tibial implant and allograft construct.Post-operatively she would later develop an infection which was never treated to eradication.She then had instability around the implant and a plate was added.This led to an additional surgery and revision without clearing the infection, resulting in the eventual removal of the screws and plates.She developed wound problems, drainage, and ultimately had to have the entire implant removed due to gross infection.The surgeon believes the requested device provides the patient the best treatment option.The surgeon identified the implantation of a non-silver prosthetic, fusion, or amputation as the alternative treatment options for this patient.Due to the patient's young age, high risk of infection, increased risk of complications associated with the alternatives, and poor functional outcomes, the surgeon believes the requested device would be in the patient's best interest." the investiongation is not completed yet.The device has not been explanted yet.The revision surgery is scheduled for (b)(6) 2020.

Event Description

The patient got a custom made knee implant at the beginning of this year.It became known, that she requires revision surgery now, because of a fracture of the prox.Tibial implant and a loosening of the tibial stem.The surgeon stated that the patient goes dancing, despite he advised her no to.

• Brand Name: MUTARS®
• Type of Device: CUSTOM MADE MUTARS® MK EPORE® PROX TIBIA SMALL TIN
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• Manufacturer Contact: hans-joachim mahr ; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• MDR Report Key: 9479943
• MDR Text Key: 176938376
• Report Number: 3012523063-2019-00016
• Device Sequence Number: 1
• Product Code: HRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2024
• Device Model Number: SA1826402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 26 YR