MAUDE Adverse Event Report: IMPLANTCAST GMBH MUTARS®; MUTARS® FEMORAL STEM CEMENTED 11/120MM

Model Number 57600011

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

The suspected medical device mutars® femoral stem cemented 11/120mm is not listed/approved in the us, but is similar to the following devices listed/approved in the us: mutars® femoral stem cemented 13/120mm, mutars® femoral stem cemented 15/120mm, mutars® femoral stem cemented 17/120mm.The fractured femoral stem and the femoral component were available for optical inspection.The proximal femur shows damage, presumably due to contact with the acetabulum.The fractured surfaces of the stem show severe damage, especially at the edges.This indicates that the stem halves rubbed against each other in situ.Two distinct contours can be seen in the center of the proximal fracture surface, which may represent an impression of the edge of the distal fracture surface.The fracture surfaces are partially overgrown with tissue.Therefore, the fracture origin cannot be determined.Microscopic examination of the fracture surfaces did not reveal any defects in the casting that would have contributed to failure.The manufacturing records of the affected components were reviewed and show no indication of faulty production or deviating dimensions.The surgical technique and instructions for use are complete and show no evidence of defects.The instructions for use list implant fracture as a possible complication.A technical cause for the fracture cannot be determined on the basis of the information.The occurrence rate is below the accepted threshold.

Event Description

After approximately 7 years and 7 months in situ, one femoral stem had to be revised due to implant failure.

• Brand Name: MUTARS®
• Type of Device: MUTARS® FEMORAL STEM CEMENTED 11/120MM
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• MDR Report Key: 18334753
• MDR Text Key: 330598447
• Report Number: 3012523063-2023-00020
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57600011
• Device Lot Number: 84706901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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
• Treatment: 2M IMPLACROSS® E HEAD Ø 28/44MM, REF:29052844; ECOFIT® 2M CUP CEMENTLESS Ø 44/48MM, REF:02201048; IC-HEAD COCRMO TAPER 12/14MMØ 28MM,XL,REF:23872815; MUTARS® PROX. FEMUR 50MM SILVER, REF:57100205S; MUTARS® SCREW M10X25MM, REF: 57921002
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 65 KG