MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D15X92MM CEMENTED; KNEE ENDOPROSTHETICS

Model Number NR195Z

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/03/2017

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 tibia.The pre-operative diagnosis in (b)(6) 2016 was status post knee revision with multi-directional instability.The patient was initially implanted with enduro components on (b)(6) 2016.The type of cement used in this surgery was one-on-one with tobramycin placement of stimulan antibiotic load pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.She experienced a fall in (b)(6) 2017 and had complaints of pain; imaging results showed a peri-prosthetic tibial fracture.There was a failed right total knee, revision due to failure of the tibial implant with some black debridement on (b)(6) 2017.A revision surgery was necessary.The implant that was revised was the aesculap enduro tibia.There had been signs of loosening but no acute inflammation.Treatment provided included intraoperative ancef and also tranexamic acid.Additional information was requested.The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2020-00101 ((b)(4) nb037z).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00101 (400468255 nb037z).General information we received a complaint regarding enduro components from the medical center of plano, usa.This is one of 12 cases regarding "problems with enduro components", "implant loosening" and "black debris".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.In this case it could be probable that the failure is partially patient related.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.Corrective action: product safety case was created.

• Brand Name: AS TIBIA OFFSET STEM D15X92MM CEMENTED
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9938259
• MDR Text Key: 187417102
• Report Number: 9610612-2020-00137
• 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: 06/30/2020

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: NR195Z
• Device Catalogue Number: NR195Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR