MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR.; STEMS (IMPLANTS) COLUMBUS

Model Number NR400K

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).It was reported that the axis was broken.All medwatch submissions related to this report are: 9610612-2018-00118, 9610612-2018-00119.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with the digital microscope vhx-5000 keyence and the digital- camera "panasonic dmc tz8".Furthermore this case was discussed with a specialist from the product management.The nr400k is broken at the thread.The fracture surface exhibit no material defects like foreign particles inclusions or blow holes.The broken part in the femurbox was investigated in the scanning-electron-microscope the scanning-electron-microscope pictures indicate that it is a fatigue fracture.On the nb016203 - hinge ring f3 are visible signs of a hyperextension.The impression is visible and touchable.The femur component was implanted with wedges to correct the bone defects of the patient.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably not product related.Rational: we assume that the patient had several bone defects which were compensated for using spacers and bone cement.This led to the femur component not being supported enough and therefore the loading being transmitted through the femur box to the femur stem and the nut.Furthermore it should be mentioned that the patient has a weight of (b)(6).This circumstance strengthened the mentioned effect.No capa is necessary.

Manufacturer Narrative

Aesculap inc.(importer) is submitting this report on behalf of aesculap ag (manufacturer).Exemption number: e2014018.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: germany.It was reported that the axis was broken.All medwatch submissions related to this report are: 9610612-2018-00118 and 9610612-2018-00119.Components in use listed as concomitant devices are: nb016k / enduro femoral component cemented f3l, nb012k / enduro tibial comp.Offset cemented t2, nr195k / tibia offset stem d15x92mm cemented, nr890m / enduro meniscal component f3 10mm.

• Brand Name: NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR.
• Type of Device: STEMS (IMPLANTS) COLUMBUS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7359691
• MDR Text Key: 103180984
• Report Number: 9610612-2018-00119
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K083772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR400K
• Device Catalogue Number: NR400K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2018
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 02/21/2018; 02/21/2018
• Supplement Dates FDA Received: 03/26/2018; 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NB012K / ENDURO TIBIAL COMP. OFFSET CEMENTED T2; NB016K / ENDURO FEMORAL COMPONENT CEMENTED F3L; NR195K / TIBIA OFFSET STEM D15X92MM CEMENTED; NR890M / ENDURO MENISCAL COMPONENT F3 10MM
• Patient Outcome(s): Other