MAUDE Adverse Event Report: AESCULAP AG AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.; KNEE ENDOPROSTHETICS

Model Number NR400Z

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 as nut f/femur extens.Stem all sz.Neutr.Pre-operative diagnoses in 2018 included multidirectional instability of the left knee and pain following a left total knee arthroplasty (tka).The patient was initially implanted with enduro components on (b)(6) 2018.All components were cemented one-on-one with tobramycin and placement of stimulan pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.Amniofix was placed for retardation of scarring over the posterior capsule and the sciatic nerve.There later was a failed left total knee and revision on (b)(6) 2020, and there had been increased pain prior to surgery.Black staining of tissues was noted.A revision surgery was necessary.The implants that were revised were the aesculap enduro components.A competitor's products were used instead, a porex component hinge.Additional information was requested.The adverse event is filed under xc (b)(4).Associated medwatches: 9610612-2020-00108 ((b)(4) nr880z), 9610612-2020-00119 ((b)(4) nb015z), 9610612-2020-00120 ((b)(4) nr292z), 9610612-2020-00122 ((b)(4) nb012z), 9610612-2020-00123 ((b)(4) nr192z).

Manufacturer Narrative

Associated medwatches: 9610612-2020-00108 (400468343 nr880z); 9610612-2020-00119 (400468799 nb015z); 9610612-2020-00120 (400468800 nr292z); 9610612-2020-00121 (400468801 nr400z); 9610612-2020-00122 (400468802 nb012z); 9610612-2020-00123 (400468803 nr192z).Investigation: no product at hand, therefore an investigation at the devices is not possible.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.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.Corrective action: product safety case was created.

• Brand Name: AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR.
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9963007
• MDR Text Key: 187798316
• Report Number: 9610612-2020-00121
• 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: 07/06/2020

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: NR400Z
• Device Catalogue Number: NR400Z
• Device Lot Number: 52428200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention