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

Model Number AE-QAS-K521-99

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

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 enduro 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: corrected article code.

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 problems can not be drawn.T 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: 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: 9963334
• MDR Text Key: 187795855
• Report Number: 9610612-2020-00107
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• 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
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention