MAUDE Adverse Event Report: AESCULAP AG ENDURO FEMORAL COMPONENT CEMENTED F1R; KNEE ENDOPROSTHESES

Model Number NB017K

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 08/07/2020

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 a enduro femoral component.According to the complaint description the femoral component fractured postoperatively.A revision surgery was necessary.Initial surgery: (b)(6) 2017.Revision surgery: (b)(6) 2020.The adverse event is filed under aag reference (b)(4).Involved components: nr400k - nut f/femur extens.Stem all sizes neutr.- lot 51836787, nr870m - enduro meniscal component f1 10mm - lot 51834047, nr292k - femur extens.Stem 6° d15x77mm cemented - lot 51858201.

Event Description

The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.On examination, it was found that the medial side of the femoral box and stem had compression marks indicating leverage of the stem.The medial side was under compression and the lateral side was under tension.The femoral component was implanted with wedges to correct the patient's bone defects.Neither the fracture surface of the femoral box (main fragment) nor that of the secondary fragment fragment shows material defects/abnormalities such as foreign body inclusions or blowholes.Both fracture surfaces show signs of fatigue fracture.No signs of hyperextension are visible on the enduro hinge ring.The sliding surface of the meniscus component shows small visible scratches and marks.This is due to third body wear caused by bone cement remnants cement residue and/or small bone fragments that have entered the gliding space between the femur and the meniscal component.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ENDURO FEMORAL COMPONENT CEMENTED F1R
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10482863
• MDR Text Key: 206960362
• Report Number: 9610612-2020-00475
• 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
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2017
• Device Model Number: NB017K
• Device Catalogue Number: NB017K
• Device Lot Number: 51835982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NR292K - 51858201; NR400K - 51836787; NR870M - 51834047
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR