MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS; KNEE ENDOPROSTHETICS

Model Number AE-QAS-K521-99

Device Problems Material Fragmentation (1261); Unstable (1667)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling (2091); Weight Changes (2607)

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 patient was initially implanted with enduro components on (b)(6) 2014 for multidirectional instability and knee pain.All components were cemented with antibiotic - loaded cement with a mixture of vancomycin, fortaz, and placement of stimulan pellets with tobramycin and vancomycin.The surgery in 2014 was noted to be extremely difficult because of difficulty encountered in removing the cement mantle from the previous stem, difficulty encountered with a large amount of scar tissue, the debridement process, mobilization of the vessel and nerve, for which justified the use of a 22 modifier throughout.The patient was put on antibiotics (vancomycin) post-operatively and 6 weeks with a peripherally inserted central catheter (picc) line.The pre-operative diagnosis in 2019 was restricted range of motion, thought secondary to heterotopic bone formation in distal femur with continued pain and swelling.On (b)(6) 2019, a revision surgery was performed; during the procedure, evidence of wear and debris from the carbon fiber was found in surrounding tissue.The patient had also experienced sudden, unexplained weight loss prior to the surgery.The implant that was revised was the aesculap enduro femur.New aesculap enduro components were also implanted.The treatment included placement of antibiotic-loaded stimulan pellets with a mixture of tobramycin and vancomycin.Additional information was requested.The adverse event is filed under xc (b)(4).

Manufacturer Narrative

Section d: leading material updated (collective material number).There are no devices available for investigation.Investigation - no product at hand, therefore an investigation at the devices is not possible.This case was discussed with several specialists from the product management, development department, and biomechanic specialists.Further information was requested by the responsible surgeon.Several telephone conferences between aesculap specialists and the responsible surgeon were held in which the topic "implant loosening" and "black debris" was discussed.The investigation and further information gathering from the responsible surgeon is ongoing."psc-enduro knee- black discoloration of the tissue around the prosthesis" was created.Pictorial documentation - there are no pictures available.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 problems can not be drawn.The investigation is ongoing.Until there are 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 this 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 - a product safety case (psc) was created (see above).

Manufacturer Narrative

Section d: leading material updated.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9949029
• MDR Text Key: 187402002
• Report Number: 2916714-2020-00081
• 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
• Report Date: 06/17/2020

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: 06/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/15/2020; 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention