MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R PREVIOUSLY REPORTED

Model Number NB017Z

Device Problems Unstable (1667); Contamination /Decontamination Problem (2895); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 03/06/2019

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 enduro components. The pre-operative diagnosis in 2017 was status post total knee replacement with multi-directional instability, associated with the lumen. The patient was initially implanted with enduro components on (b)(6) 2017. The type of cement used in the initial surgery was utilized with simplex and followed by stimulan pellets with 240mg of tobramycin and 500 mg of vancomycin per mixture; and components were comented one-on-one with tobramycin. There was a failed right total knee with hinge, revision due to loosening with some evidence of black carbon debris on (b)(6) 2019. The patient had been experiencing increased pain. A revision surgery was necessary. The implant that was revised was the aesculap enduro tibia and femur. All components were cemented one-on-one with tobramycin, followed by stimulan pellets and tobramycin and vancomycin mixture. Additional information was requested. The adverse event is filed under xc (b)(4). Associated medwatch-reports: ((b)(4)), 2916714-2020-00101 ((b)(4)).

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F1R
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9933979
• MDR Text Key: 187399443
• Report Number: 2916714-2020-00082
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NB017Z
• Device Catalogue Number: NB017Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2020
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/08/2020 Patient Sequence Number: 1