MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN; KNEE ENDOPROSTHETICS

Model Number AE-QAS-K521-99

Device Problem Unstable (1667)

Patient Problems Scarring (2061); Reaction (2414)

Event Date 03/18/2020

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 femoral component.The pre-operative diagnosis in (b)(6) 2019 was multi-directional instability, right knee with arthro-fibrosis, failed right total knee, loosening of tibial stem and femoral stem, and history of infection from a total knee revision.The patient was initially implanted with enduro components on (b)(6) 2019.The type of cement used in this surgery was one-on-one with tobramycin placement of pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.There later was a failed right total knee, revision due to failure of the femoral implant with loosening but secondary to wear and debris of the carbon fiber linkage mechanism on (b)(6) 2020.The patient had been experiencing pain.Treatment included antibiotic-loaded stimulan pellets and mixture of tobramycin and vancomycin.A revision surgery was necessary.The implant that was revised was the aesculap enduro femur.A porex component from link was used as a hinge instead.It was noted that the procedure was extremely difficult which justified the use of the 22 modifier, due to the scarring and amount of wear and debris reaction.Additional information was requested.The adverse event is filed under xc (b)(4).

Manufacturer Narrative

Section d: leading material updated.

Event Description

See section d.

Manufacturer Narrative

Section d: leading material updated.

Event Description

See section d.

Manufacturer Narrative

Investigation: no product at hand, therefore an investigation at the devices is not possible.Batch history review: a review of the device quality and manufacturing history records is not possible because the material number as well as the batch number is unknown.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.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.

Event Description

No update.

• Brand Name: COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9938918
• MDR Text Key: 187397268
• Report Number: 2916714-2020-00084
• 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,Followup,Followup
• Report Date: 07/06/2020

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: AE-QAS-K521-99
• Device Catalogue Number: AE-QAS-K521-99
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/15/2020; 05/04/2020; 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR