MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 12MM; KNEE ENDOPROSTHETICS

Model Number NR881M

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with nr881m - enduro meniscal component f2 12mm.According to the complaint description, there was a revision surgery 8 months post surgery to change the femur implant.A revision surgery was necessary.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: nr293k - femur extens.Stem 6° d18x77mm cemented - lot 52624669.Nb012k - enduro tibial comp.Offset cemented t2 - lot 52647195.Nx043 - patella 3-pegs p3 - lot 52624197.Nb015k - enduro femoral component cemented f2l - lot 52637143.Nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52627686.Nr195k - tibia offset stem d15x92mm cemented - lot 52640922.

Event Description

Update: a distal femur replacement was performed in september 2021.During the surgery, the meniscal component was changed.And it was noted that the removed rotation axis could not be moved in the bearing for the rotation axis.The rotation axis and bearing were available for investigation.

Manufacturer Narrative

Investigation: visual inspection: the provided explants were in a decontaminated condition.Only 2 components were provided.In its incoming condition, the bearing for the rotation axis was still fixed on the rotation axis.With a little effort, it was possible to remove and separate them.The surface of the rotation axis shows all the way around visible residues.These residues were analyzed in our internal aag laboratory.The analysis results showed approximately 91 % agreement with dry blood.The case was also discussed with several specialists from the product management and development department.Batch history review: the device quality and manufacturing hisotry records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specifiaction valid at the time of production.There are no similar complaints aginst the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.In this case the product risk analysis is only conditionally applicable because the root cause for the mentioned problems remains unclear.Furthermore, the mentioned sluggishness of this 2 parts cannot be evaluated as an error per se.Explanation and rationale: on the basis of the current information, a clear conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.As mentioned above, this case was discussed with several specialists from the product management and development department.The root cause for the revision operation (2021-09-29) was the circumstance that the femur fracture which was treated with plate and cercelages (2021-06 / rev.1) failed.In the course of this, the meniscal component was changed -> thereby it was notice that the explanted rotation axis could only be moved with difficultly in the bearing for the rotation axis.After consultation with specialists from the product management and development department it can be assumed that the sluggishness between the two components was caused due to the residues on the surface of the rotation axis.How these residues got between the rotation axis and the bearing remains unclear.A possible root cause for this could be that due to the temporary immobility of the patient, these residues (blood, body fluids) got between the rotation axis and the bearing.But this is only speculative.In the implanted state under normal conditions (movement), the mentioned sluggishness of this two parts would hardly have been noticed and thus would not have been recognized as a defect.Without further information the root cause for the mentioned periprosthetic distal femur fracture and the subsequent failure of the plate and cercelage treatment also remains unclear.A possible root cause for this could be that the used enduro system is the wrong therapy for this patient.This is also speculative.It cannot be assumed that the used implants are causal for the mentioned problems.The mentioned circumstances/difficulties are rather patient-related/usage-related.Conclusion: due to the current deviation and according to the explanation and rationale, the root cause of the problem is most probably patient and usage-related.Corrective action: based upon the investigations results a capa is not necessary.

• Brand Name: ENDURO MENISCAL COMPONENT F2 12MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12673882
• MDR Text Key: 277686689
• Report Number: 9610612-2021-00673
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR881M
• Device Catalogue Number: NR881M
• Device Lot Number: 52622630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2020
• 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: NB012K - LOT 52647195; NB015K - LOT 52637143; NR195K - LOT 52640922; NR293K - LOT 52624669; NR400K - LOT 52627686; NX043 - LOT 52624197; NB012K - LOT 52647195; NB015K - LOT 52637143; NR195K - LOT 52640922; NR293K - LOT 52624669; NR400K - LOT 52627686; NX043 - LOT 52624197
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR