MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIAL COMP.OFFSET CEMENTED T2; KNEE ENDOPROSTHETICS

Model Number NB012Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Disorder (2373)

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 vacomycin mixture.Additional information was requested.The adverse event is filed under xc (b)(4).Associated medwatch-reports: 9610612-2020-00100 ((b)(4)).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00136 ((b)(4)).General information: we received a complaint regarding enduro components from the medical center of (b)(6) usa.This is one of 12 cases regarding "problems with enduro components", "implant loosening" and "black debris" from dr.(b)(6) medical center of (b)(6).Up to now, there are no devices available for investigation.Consequences for the patient: post-operative medical intervention was necessary -> revision surgery.Investigation: no product at hand, therefore an investigation at the devices is not possible.Batch history review: due to the fact that no lot numbers were provided, a review of the device history records must remain incomplete.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure at that time.Rationale: on the basis of the current information and without a product for investigation, a clear conclusion/root cause for the implant loosening can not be drawn.The investigation is ongoing.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.At that time it is not possible to verify if the black staining/debris is responsible for the implant loosening.There are many potential sources regarding to implant loosening: · modification/ change in the surgical technique.· cement technique.· patient fall.· patient allergy/infection.Corrective action: product safety case was created.

• Brand Name: AS ENDURO TIBIAL COMP.OFFSET CEMENTED T2
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9963015
• MDR Text Key: 187793850
• Report Number: 9610612-2020-00136
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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: NB012Z
• Device Catalogue Number: NB012Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention