MAUDE Adverse Event Report: AESCULAP AG AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.; PREVIOUSLY SUBMITTED

Model Number NR400Z

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Discoloration (2074)

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 nut f/femur extension.Following information was reported: the original date of surgery was (b)(6) 2016 for a right total knee replacement.The patient was revised on (b)(6) 2019.Black staining of the soft tissue surrounding the implant was noted by the surgeon, followed by extraction of the femoral components.There was also a polyethylene swap; the implants were replaced by new enduro components.A revision surgery was necessary.Additional information was not yet provided nor available.The adverse event is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00912 ((b)(4) nb018z), 9610612-2019-00913 ((b)(4) nr865z), 9610612-2019-00914 ((b)(4) nr295z), 9610612-2019-00916 ((b)(4) nr400z), 9610612-2019-00915 ((b)(4) nr882z), 9610612-2019-00917 ((b)(4) ae-qas-k521-55).

Manufacturer Narrative

Clarification: on 24.01.2020 we received the decontaminated products and found out that nb012z (batch 52041408) is the correct item code for complaint 400458627, and the information was updated.Furthermore we created an additional cc(400462509) for item code nr192z (batch 51972344) which we received on 24.01.2020.Associated medwatch-reports: 9610612-2019-00912 (b)(4), 9610612-2019-00913 (b)(4), 9610612-2019-00914 (b)(4), 9610612-2019-00916 (b)(4), 9610612-2019-00915 (b)(4), 9610612-2019-00917 (b)(4), 9610612-2019-01011 (b)(4).General information: we received a complaint regarding "po revision due to staining" from the medical center of plano, 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.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.A part of the femoral bone is still fixed on the prosthesis stem.The provided devices show no external damages or abnormalities.The metal surface of the provided explants show no abnormal metal abrasion.During the investigation it was found that the hinge ring moves more sluggishly (moving by hand) than usual.Furthermore it could be determined that the rotation axis stucks absolutely tight in the tibial component, respective in the bearing.The intended movement is no more possible.This is not directly related with the black staining of the tissue.As a next step the locking ring was loosened with the instruments for this purpose.The recess for the rotation axis in the tibial component shows extreme dirt and residues of unknown nature.Regarding this an edx analyses was implemented to identify and verify the mentioned dirt and residues.The result of this analyses is pending.Furthermore it could be found that the peek parts, which are in direct contact with the hinge ring show little damages and abrasions.It is not possible to determine if this peek abrasion/damages is responsible for the mentioned black staining of the soft tissue surrounding the implant.The bearing shows also no abnormal material abrasion.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 (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

No updates.

Manufacturer Narrative

Clarification b5: on 19mar2020 additional information was received and 2 complaints were created for the patient, referencing the left knee arthroplasties.(b)(4); 2916714-2020-00094.(b)(4); 2916714-2020-00102.Associated medwatch-reports: right knee arthroplasties 9610612-2019-00912 ((b)(4); nb018z).9610612-2019-00913 ((b)(4); nr865z).9610612-2019-00914 ((b)(4); nr295z).9610612-2019-00916 ((b)(4); nr400z).9610612-2019-00915 ((b)(4); nr882z).9610612-2019-00917 ((b)(4); nb012z).9610612-2019-01011 ((b)(4);nr192z).

Event Description

Pre-op diagnosis: 2019 massive osteolysis to both the fibia and femur of the right knee.Operative findings: 2019 loosened cement mantles bilaterally with a black staining tissue, in both canals.Medical treatment provided: tobramycin, antibiotic stimulan pellets, vancomycin.

Event Description

No updates.

Manufacturer Narrative

Associated medwatch reports - referencing the left knee arthroplasties.(400469058) 2916714-2020-00094 (400469059) 2916714-2020-00102 associated medwatch-reports: right knee arthroplasties 9610612-2019-00912 (400458621 nb018z) 9610612-2019-00913 (400458623 nr865z) 9610612-2019-00914 (400458624 nr295z) 9610612-2019-00916 (400458625 nr400z) 9610612-2019-00915 (400458626 nr882z) 9610612-2019-00917 (400458627 nb012z) 9610612-2019-01011 (400462509 nr192z) updated investigation: 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.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.A product safety case (psc) was opened.

• Brand Name: AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.
• Type of Device: PREVIOUSLY SUBMITTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9643500
• MDR Text Key: 176989008
• Report Number: 2916714-2020-00010
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR400Z
• Device Catalogue Number: NR400Z
• Device Lot Number: 52213394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2020; 04/08/2020; 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR