MAUDE Adverse Event Report: IMPLANTCAST GMBH MUTARS®; MUTARS® DIST. FEMUR M-O-M 110MM RIGHT SILVER INCL. SAFETY SCREW

Model Number 57200040S

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The concerned device is part of a compassionate use request and therefore a "compassionate use device".The approval no.For this case is # (b)(4).Damage analysis.Optical inspection.An optical inspection of the affected medical device could not be performed.The device is implanted and thus not available for inspection.Assessment of the manufacturing protocols.The manufacturing protocols of the medical devices listed in table 1 were checked.These show no deviations.The release dates are listed in table 1.Furthermore, a sterility lot review was performed.The certificates of sterilization were reviewed.These show no deviations.Assessment of the dimensional accuracy of the construction as no product is available for inspection, an assessment of the dimensional accuracy could not be performed.Functional testing.As no product is available for inspection, a functional testing could not be performed.Assessment of the mechanical properties.The approval of the basic materials was performed.External evaluation.As no explant is available for inspection, an external evaluation was not commissioned.Assessment of the medical records.Patient gender: male, age at time of event: ca.(b)(6) years, weight: unknown, height: unknown, bmi: unknown.Date of implantation: (b)(4) 2019.Explantation date: in situ.Degree of activity: low.Surgical technique and instructions for use.The surgical technique 'mutars® distal femur mk st' describes the complete implantation process in detail.There are no indications of an incorrect or incomplete surgical technique.The instruction for use (ifu) 'mutars® tumor- and revision system' was checked.There is no indication of incorrect instructions for use.Infections is labelled in complication.Categorisation and interpretation of the results.A sterility lot review was performed reviewing the certificates of sterilization.The certificates are an evidence that the concerned products were sterile when they left implantcast (b)(4).Furthermore, a packaging and cleaning lot review was performed.All implants went through the cleaning and packaging steps properly.Based on the analysis of the production records, no deviations were detected.Therefore, it can reasonably be assumed that the infection was not caused by the device due to the device not being sterile.Risk analysis and trend evaluation.The risk analysis of the mutars® system established an accepted rate of (b)(4) for infection ('risk analysis report_mutars_rev 5', date (b)(6) 2017).In the past 3 years, 18 cases have been brought to implantcast's attention.During the past three years, the 18 cases of the event "infection" were brought to implantcast's attention in which an infection has occurred in context with an implantcast product (see table 2 - similar cases).11 of these cases (including the present one) refer to a product of the mutars® system.Table 3 shows a trend analysis.The small number of cases is subject to temporal fluctuations.A steady increase could not be observed.Measures no measures required.Summary: a (b)(6)-year-old male patient suffering from a chronically infection in the knee area was implanted an mutars® knee system with silver coating.After the surgery, the patient developed infectious complications again.A sterility lot review was performed reviewing the certificates of sterilization.The certificates are an evidence that the concerned products were sterile when they left implantcast (b)(4).Furthermore, a packaging and cleaning lot review was performed.All implants went through the cleaning and packaging steps properly.Based on the analysis of the production records, no deviations were detected.Therefore, it can reasonably be assumed that the infection was not caused by the device due to the device not being sterile.An infection is labelled in the current ifu of the mutars® ifu and part of the risk management system of the mutars® system.The alternative treatments available for this patient are arthrodesis of his right knee with an intramedullary device and vascularized fibular intercalary graft; amputation of his right leg above the knee; amputation of his right leg using a lower extremity rotationplasty technique; and replacing a standard modular oncology knee and distal femoral implant (approval letter fda dated 10-jul-2018).No measures required.(b)(4).

Event Description

Implantcast received the following report from the us distributor on (b)(6) 2020: "infection: (b)(6) cultures grew (b)(6) epidermis.Per the surgeon i&ds have since been performed.".

• Brand Name: MUTARS®
• Type of Device: MUTARS® DIST. FEMUR M-O-M 110MM RIGHT SILVER INCL. SAFETY SCREW
• 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: 9910427
• MDR Text Key: 188008871
• Report Number: 3012523063-2020-00003
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2024
• Device Model Number: 57200040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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: 55 YR