MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F3 12MM; GLIDING SURFACES/PATELLAS ENDU

Model Number NR891

Device Problem Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Height 178cm.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "on (b)(6) 2011, the patient had right knee prosthesis with an enduro device.Following hip tep implantation on the right hip, on (b)(6) 2018, during a physiotherapeutic treatment the patient felt a crack with subsequent instability in the area of the right knee joint.The patient was seen for doctor consultation on (b)(6) 2018.After appropriate diagnostics a revision of the knee prosthesis was performed." components in use listed as concomitant medical products are: nr891, enduro meniscal component f3 12mm (this report / leading material); nb019k, enduro femoral component cemented f3r; nr172k, tibia offset stem d12x92mm cementless; nb012k, enduro tibial comp.Offset cemented t2; nr410k, femur extens.Stem 5° d20x117mm cem.Less; nr400k, nut f/femur extens.Stem all sizes neutr; refobacin bone cement r40 btl/2.

Manufacturer Narrative

Investigation: the components were examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.It was found that the rotation axis has fractured below the taper.The taper of the rotation axis shows visible damage on the surface.The rotation axis locknut is no longer located/fixed on the thread of the axis.The breakage surface of the larger distal part of the axis as well as the proximal fragment show so called arrest lines which are typical for a dynamic fatigue fracture.Both fracture surfaces exhibit no material defects like foreign particles, inclusions, or blow holes.The thread of the rotation axis as well as the thread of the rotation axis locknut shows no visible damages.It was determined that the meniscal component exhibits several signs of wear (not unusual for 7 years implanted).The gliding surface shows anterior visible delaminations.The locking ring and the bearing for rotation axis show no unusual damages.The available x-ray figures do not provide any hints for the rotation axis fracture cause.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from the batch.Conclusion and root cause: based on the information available, as well as the results of our investigation, the root cause of the failure is probably patient/usage related.Rationale: according to the quality standard and dhr files a material defect and production error can be excluded.Furthermore there are not hints of a material or manufacturing problem.The fracture surface exhibit no material defects like foreign particles inclusions or blow holes.We assume that the fracture appears to have occurred due to a patient related mechanical overload situation.It could be possible that the mentioned physiotherapeutic treatment because of the hip tep implantation intensified a mechanical overload situation.Furthermore, it should be mentioned that the visible damages on the taper of the rotation axis could be an indication that the hinge connection of the femur has been moving on the taper.No capa is necessary.

• Brand Name: ENDURO MENISCAL COMPONENT F3 12MM
• Type of Device: GLIDING SURFACES/PATELLAS ENDU
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8294853
• MDR Text Key: 134733460
• Report Number: 9610612-2019-00011
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Model Number: NR891
• Device Catalogue Number: NR891
• Device Lot Number: 51598095
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/15/2019
• Device Age: 10 YR
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NB012K, ENDURO TIBIAL; NB019K, ENDURO FEMORAL; NR172K, TIBIA OFFSET STEM; NR400K, NUT F/FEMUR; NR410K, FEMUR EXTENS; NR891, ENDURO MENISCAL; REFOBACIN BONE CEMENT R40 BTL/2
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 125