MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 10MM; KNEE ENDOPROSTHESES

Model Number NR880M

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Disorder (2373); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Investigation results: to date there is no device available for investigation.Up to now there are only little information regarding the failure type available.No pictures or x-ray figure were provided.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 these batches.On the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Based on our experience of previous incidents, it might be possible that the rotation axis has fractured above the taper.For further investigations we need the device for examination.A capa is not necessary.

Event Description

It was reported that there was an issue with a enduro knee implant.According to the complaint description, the implant loosened postoperatively after 4 years and 9 months.It was noted that there had been a chronic reaction over a long period of time; the more the patient walked, the symptoms worsened.Primary surgery: (b)(6) 2015.Revision surgery: (b)(6) 2020.Explants are not available at the moment.Still under consideration.A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Involved components: nr293k - femur extens.Stem 6° d18x77mm cemented - lot 52087343.Nr193k - tibia offset stem d18x52mm cemented - lot 52091491.Nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52122426.Nb018k - enduro femoral component cemented f2r - lot 52159429.Nb012k - enduro tibial comp.Offset cemented t2 - lot 52166484.Nk916 - imset resorb.Intramedullary plug 16mm - lot 52102726.Nk918 - imset resorb.Intramedullary plug 18mm lot 52057405.

Manufacturer Narrative

Reference code nb018k.Device name enduro femoral component.Cemented f2r.Serial number: n/a.Batch number: 52159429.Udi device identifier: (b)(4).Udi production identifier: (b)(4).Basic udi-di: n/a.Unit of use udi-di: (b)(4).Manufacturing date: 2015-07-14.Ref code/ device name batch nr.Nr293k, femur extens.Stem 6° d18x77mm cemented, 52087343.Nr193k, tibia offset stem d18x52mm cemented, 52091491.Nr400k, nut f/femur extens.Stem all sizes neutr., 52122426.Nr880m, enduro meniscal component f2 10mm, 52159165.Nb012k, enduro tibial comp.Offset cemented t2, 52166484.Nk916, imset resorb.Intramedullary plug 16mm, 52102726.Nk918, imset resorb.Intramedullary plug 18mm, 52057405.Failure description: the lateral side of the box of the femur component has fractured.Investigation: the components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The box of the femur component has pulled out at the lateral side at the interface to the femur shaft.The medial side of the femur box as well as the medial side of the stem exhibits pressure marking showing a leverage of the stem.Medial side was under compression and lateral was under tension.The femur component exhibits bone cement with interdigitation to cancellous bone especially medial - anterior.There are only little bone cement residues on the lateral side of the femur component with hardly visible traces of interdigitation to cancellous bone.The provided x-ray figure shows signs of implant loosening.Neither the fracture surface of the femur box (major fragment) nor that of the minor fragment exhibits material defects/abnormalities like foreign particles inclusions or blow holes.Both fracture surfaces show signs of a fatigue fracture.The crack initiation is assumed at the ventral edge of the lateral side of the box.On the enduro hinge ring shows clearly visible signs of a hyperextension.The impression is visible and palpable.The gliding surface of the meniscal component shows visible scratches and imprints.The reason for this is third body wear, caused by bone cement residues and/or small bone parts which entered the sliding space between the femur and meniscal component.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: according to the quality standard and dhr files a material defect and production error can be excluded.We assume that the primary stability of the femoral component was insufficient due to the mentioned implant loosening.This led to the femur component not being supported and the loading being transmitted through the femur box to the femur stem.The femur stem was held primarily by the connection to the femur stem.The femur component box (at the interface) has therefore been dynamically loaded which has resulted in a fatigue fracture.The definitive root cause for the loosening of the femur component cannot be conclusively clarified.We assume that bone degeneration/bone defects is mainly responsible for the femur loosening.Conclusion and root cause: due to the current deviation and according the rationale, the root cause of the problem is most probably patient - related.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

Event Description

Involved components: nr293k - femur extens.Stem 6° d18x77mm cemented - lot 52087343.Nr193k - tibia offset stem d18x52mm cemented - lot 52091491.Nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52122426.Nb018k - enduro femoral component cemented f2r - lot 52159429.Nb012k - enduro tibial comp.Offset cemented t2 - lot 52166484.Nk916 - imset resorb.Intramedullary plug 16mm - lot 52102726.Nk918 - imset resorb.Intramedullary plug 18mm lot 52057405.

Manufacturer Narrative

See b5 update information.

Event Description

After the 8 d report the leading material is changed from 9610612-2020-00341 (400477770) to 9610612-2020-00708(400478133).Involved components: nr880m- enduro meniscal component f2 10mm- 52159165.Nr293k - femur extens.Stem 6° d18x77mm cemented - lot 52087343.Nr193k - tibia offset stem d18x52mm cemented - lot 52091491.Nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52122426.Nb012k - enduro tibial comp.Offset cemented t2 - lot 52166484.Nk916 - imset resorb.Intramedullary plug 16mm - lot 52102726.Nk918 - imset resorb.Intramedullary plug 18mm lot 52057405.

• Brand Name: ENDURO MENISCAL COMPONENT F2 10MM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10346056
• MDR Text Key: 207914852
• Report Number: 9610612-2020-00341
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: NR880M
• Device Catalogue Number: NR880M
• Device Lot Number: 52159165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NB012K - LOT 52166484.; NB012K - LOT 52166484.; NB012K - LOT 52166484.; NB018K - LOT 52159429.; NB018K - LOT 52159429.; NK916 - LOT 52102726.; NK916 - LOT 52102726.; NK916 - LOT 52102726.; NK918 - LOT 52057405.; NK918 - LOT 52057405.; NK918 - LOT 52057405.; NR193K - LOT 52091491.; NR193K - LOT 52091491.; NR193K - LOT 52091491.; NR293K - LOT 52087343.; NR293K - LOT 52087343.; NR293K - LOT 52087343.; NR400K - LOT 52122426.; NR400K - LOT 52122426.; NR400K - LOT 52122426.; NR880M-52159165.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR