MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 6° D18X157 CEMENTED; KNEE ENDOPROSTHETICS

Model Number NR296Z

Device Problem Compatibility Problem (2960)

Patient Problem Foreign Body Reaction (1868)

Event Date 12/30/2019

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 as femur extens.Stem.Following information was reported: the patient was initially implanted with enduro components on an unspecified date.A right total knee revision was performed with removal of enduro components on (b)(6) 2019.The implants were replaced with link distal femoral implant.Black staining of the surrounding soft tissue was noted by the surgeon during the procedure.A revision surgery was necessary.It was noted that the revision was due to the staining.Additional information was requested.The adverse event is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00906 ((b)(4)), 9610612-2019-00907 ((b)(4)), 9610612-2019-00908 ((b)(4)).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00906 ((b)(4) nb018z); 9610612-2019-00907 ((b)(4) nr296z); 9610612-2019-00908 ((b)(4) nr880z).General information: we received a complaint regarding "po revision due to staining" from the medical center of plano, usa.The provided device were delivered in a contaminated condition, therefore the components were decontaminated internally according to internal standards.Consequences for the patient: post-operative medical intervention was necessary -> revision surgery.2 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".Furthermore this case was discussed with several specialists from the development department and product management.Until there are no valid results from a laboratory investigation regarding tissue samples with the mentioned black staining, it is not possible to determine to origin of the discoloration of the soft tissue.The provided devices show no external damages or abnormalities.The metal surface of the provided explants show no abnormal metal abrasion.It could be found that the peek parts, which are in direct contact with the hinge ring show little abrasions.It is not possible to determine if this peek abrasions are responsible for the mentioned black staining of the soft tissue surrounding the implant.Furthermore it could be determined that the surface of the rotation axis is partly covered with up to now unknown residues.Furthermore there are dark discolored areas located on the surface of the rotation axis regarding this an edx analyses was implemented to identify this residues.The result of this analyses is pending.The gliding surface of the meniscal component shows visible scratches it could be possible that this traces come from bone cement residues which get into the articulation between the femoral component and the gliding surface.The provided x-ray figures show no hints regarding the root cause for the black staining.In the meantime a telephone conference was held regarding the "the black staining" with specialists from the product management, an expert from r&d and the attending surgeon from usa.In this telephone conference was agreed that the provided explant components could be disassembled for further investigations.The idea is to separate the peek components for special investigation regarding unusual material abrasion/material inclusion.Due to the special corona situation at that time, this investigation is still outstanding.This 8 d report will be continuously updated with new information/ investigation results.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 these batches.Conclusion and root cause: based on the information available and the result of our investigation it is not possible to determine a definitive root cause for the failure.We do not consider that the mentioned failure is product related.Rationale: until there are no valid results from a laboratory investigation regarding tissue samples with the mentioned black staining, it is not possible to determine to origin of the discoloration of the soft tissue.It is therefore not possible to determine a definitive root cause for the mentioned black staining.There are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.Corrective action: "psc-2020-019-enduro knee- black discoloration of the tissue around the prosthesis" was created.

Event Description

Additional patient medical history was provided: the initial surgery occurred on (b)(6) 2016 and components were explanted on (b)(6) 2019.The products revised were nb018z, nr296z.Medical treatment provided: 2016 total knee arthroplasty (tka) with debridement, treated with tobramycin & vancomycin,antibiotic-loaded stimulan pellets, ancef postoperatively operative findings: 2019 tka - failed right tka, loosening of femoral component possibly tibia with reaction.

Manufacturer Narrative

B section - patient information updated associated medwatch-reports: 9610612-2019-00906 ((b)(4) nb018z); 9610612-2019-00907 ((b)(4) nr296z) report for this case; 9610612-2019-00908 ((b)(4) nr880z).General information: we received a complaint regarding "po revision due to staining".The provided device were delivered in a contaminated condition, therefore the components were decontaminated internally according to internal standards.Consequences for the patient: post-operative medical intervention was necessary -> revision surgery.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".Furthermore this case was discussed with several specialists from the development department and product management.Until there are no valid results from a laboratory investigation regarding tissue samples with the mentioned black staining, it is not possible to determine to origin of the discoloration of the soft tissue.The provided devices show no external damages or abnormalities.The metal surface of the provided explants show no abnormal metal abrasion.It could be found that the peek parts, which are in direct contact with the hinge ring show little abrasions.It is not possible to determine if this peek abrasions are responsible for the mentioned black staining of the soft tissue surrounding the implant.Furthermore it could be determined that the surface of the rotation axis is partly covered with up to now unknown residues.Furthermore there are dark discolored areas located on the surface of the rotation axis.Regarding this an edx analyses was implemented to identify this residues.The result of this analyses is pending.The gliding surface of the meniscal component shows visible scratches.It could be possible that this traces come from bone cement residues which get into the articulation between the femoral component and the gliding surface.The provided x-ray figures (see fig.10) show no hints regarding the root cause for the black staining.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 these batches.Conclusion and root cause: based on the information available and the result of our investigation it is not possible to determine a definitive root cause for the failure.We do not consider that the mentioned failure is product related.Rationale: until there are no valid results from a laboratory investigation regarding tissue samples with the mentioned black staining, it is not possible to determine to origin of the discoloration of the soft tissue.It is therefore not possible to determine a definitive root cause for the mentioned black staining.There are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.According to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: AS FEMUR EXTENS.STEM 6° D18X157 CEMENTED
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9649173
• MDR Text Key: 177143330
• Report Number: 9610612-2019-00907
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR296Z
• Device Catalogue Number: NR296Z
• Device Lot Number: 52175068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention