MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT BASIS COMPACT; ORTHOPILOT NAVIGATION SYSTEM

Model Number FS101

Device Problem Compatibility Problem (2960)

Patient Problem Unspecified Infection (1930)

Event Date 11/26/2019

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 orthopilot basis.Following customer information was reported: study: (b)(6).The implantation was on (b)(6) 2019.Postoperative (po) suspicion of early infection.Therapeutic measures: puncture, anticoagulation therapy, pt, medication.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under (b)(4).Involved components: nx057k - vega ps tibial plateau cemented t4 - 52360588a, nx140 - vega ps gliding surface t4/4+ 10mm - 52421371, nx033k - vega ps femoral component cemented f6n r - 52530600.

Manufacturer Narrative

Involved components: nx057k vega ps tibial plateau cemented t4 52360588a.Nx140 vega ps gliding surface t4/4+ 10mm 52421371.Nx033k vega ps femoral component cemented f6n r 52530600.General information: we received a complaint about one fs101.Orthopilot basis compact.The product is not available for investigation.Consequences for the patient: post-operative medical intervention was necessary : revision operation.Batch history review: the device history records have been checked for the available lot number(s) and found to be according to the specification, valid at the time of production.There is no indication for a manufacturing error or a material failure.There are no similar complaints against the same lot number.Conclusion and root cause: the root cause of the problem is most probably usage or patient related.Rationale: unfortunately due to a lack of data and without the product we can not determine the exact cause.According to the quality standard and dhr files a material defect and production error can be excluded.An infection cannot result due to the product fs101 or due to the implant components.An infection is caused by microorganisms.There are several ways the infection due to microorganisms could have been triggered.One point could be the handling during surgery.The causes and triggers for peripheral pulmonary artery embolism according to research, the following can be the case: "there are certain high-risk patients who are prone to thromboses and thus to pulmonary embolisms.Disposing factors are in the patient's history: fracture (hip or leg), total hip or knee replacement, major surgery, lung disease, hormone replacement therapy, malignant tumor, oral contraception, stroke, pregnancy, phase shortly after birth, previous venous embolism, blood clotting disorder, advanced age, high homocysteine levels.With the appropriate predisposition, any immobilization, especially of the lower limbs, can then become a trigger that, through stasis of the blood, promotes the growth of a thrombus (similar to "condensation"): blood stasis with a long bent knee, e.G.During long bus trips or long-distance flights, travel thrombosis, after fractures and sprains as well as bedriddenness of any kind.The time of acute onset, on the other hand, is determined only by the later detachment of a thrombus and its infiltration into the lungs.This typically occurs through mobilisation after resting, i.E.Sometimes well after getting up, during pressing (defecation) and other initial physical exertion afterwards.What they all have in common is the sudden change in blood pressure in the venous system with a dilatation of the vessels after inactivity".(source: a.Rahimtoola, j.D.Bergin: acute pulmonary embolism: an update on diagnosis and management.In: current problems in cardiology.2005 feb;30(2), pp.61-114.).The cause for haemarthrosis and patella luxation could not be determined.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

• Brand Name: ORTHOPILOT BASIS COMPACT
• Type of Device: ORTHOPILOT NAVIGATION SYSTEM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9728660
• MDR Text Key: 182298452
• Report Number: 9610612-2019-00953
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K080547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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: FS101
• Device Catalogue Number: FS101
• Device Lot Number: 51589952
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NX033K-52530600; NX057K - 52360588A; NX140-52421371
• Patient Outcome(s): Required Intervention