MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T1 12MM RL/LM; PREVIOUSLY REPORTED

Model Number NB037Z

Device Problem Break (1069)

Patient Problems Fall (1848); Failure of Implant (1924)

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 tibial components.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 is filed under xc (b)(4).Associated medwatch-reports: ((b)(4)), 2916714-2020-00089 ((b)(4)).

Manufacturer Narrative

Associated medwatch-reports: 2916714-2020-00078 (400468255).2916714-2020-00089 (400468931).General information we received a complaint regarding enduro components.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.

Event Description

No updates.

• Brand Name: AS ENDURO TIBIA HEMI-WEDGE T1 12MM RL/LM
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9934080
• MDR Text Key: 187397071
• Report Number: 2916714-2020-00078
• 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
• Report Date: 07/01/2020

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: Health Professional
• Device Model Number: NB037Z
• Device Catalogue Number: NB037Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR