MAUDE Adverse Event Report: IMPLANTCAST GMBH MUTARS®; MUTARS® FEMORAL STEM CEMENTED 13/120MM

Model Number 57600013

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  Injury  

Event Description

The following event was reported to implantcast gmbh: "after removing all implants include previous stem the surgeons rinsed with a pulse lavage, and inserted a cemented 13mm/120 stem including cement by using the stem adapter.When cement dried, they connected a proximal femoral component 50/135 and inserted an n10*25 screw which couldnt go throw the threads of the cemented stem which was clear and clean at its proximal part.I opened another m10*25 screw so maybe that will work but unfortunately after one and a half turns it resisted and only partially locked the femoral part to the stem.Patient has the prosthesis inside and isnt fully locked.".

Manufacturer Narrative

During implantation of a proximal femoral replacement, complications occurred with a mutars® femoral stem cemented.The mutars® screw m10x25mm could not be fully inserted to connect the stem to the proximal femur.The use of another mutars® screw m10x25mm did not help either.The screw was left as is and a head two sizes larger was chosen to increase stability.This event result in a total extension of operating time of about 35 minutes.The manufacturing documents and material certificates were checked.No errors were found.The review of the surgical technique and the instructions for use also did not reveal any errors or incompleteness.Neither the explants nor intraoperative taken pictures were available for optical examination.Due to the limited data available, no cause for the described event could be determined.As the manufacturing documents do not show any deviations and no other incidents have become known for products of the same batches, it is assumed that there is currently no evidence for a technical failure.For the failure pattern "incompatibility", the calculated occurrence rate is 0.02% and thus below the value of 4.2% specified in the risk management.

• Brand Name: MUTARS®
• Type of Device: MUTARS® FEMORAL STEM CEMENTED 13/120MM
• 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: 16917604
• MDR Text Key: 315064279
• Report Number: 3012523063-2023-00004
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K200045
• 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: 05/12/2023

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: 57600013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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: CORTINA HIP STEM CEMENTED STANDARD 2/200MM RIGHT; IC-BIPOLAR HEAD COCRMO Ø 28/48MM; IC-HEAD COCRMO TAPER 12/14MM Ø 28MM, L; MUTARS® PROX. FEMUR REVISION 50/135°; MUTARS® SCREW M10X25MM; MUTARS® SCREW M10X25MM; SAFETY SCREW
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female