MAUDE Adverse Event Report: AESCULAP AG ENDURO FEMORAL COMPONENT CEMENTED F3R; KNEE ENDOPROSTHESES

Model Number	NB019K
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: visual investigation: the lateral side of the box of the femur component has fractured.The provided components were examined visually and microscopically.The box of the femur component has pulled out at the lateral side at the interface to the femur shaft.The medial side of the femur box as well as the medial side of the stem exhibits pressure marking showing a leverage of the stem.Medial side was under compression and lateral was under tension.Neither the fracture surface of the femur box (major fragment) nor that of the minor fragment exhibits material defects/abnormalities like foreign particles inclusions or blow holes.Both fracture surfaces show signs of a fatigue fracture.The enduro hinge ring shows visible signs of damages/scratches.It remains unclear whether these traces originate from a hyperextension.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 4(5) x probability of occurrence 2(5)) 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.
Event or Problem Description
It was reported to aesculap ag that an enduro femoral component cemented f3r (part # nb019k) was implanted during a primary surgery performed on (b)(6) 2015.According to the complainant, there was a material fracture at the junction of femoral shield and stem.Implantation was done during tracheoesophageal puncture (tep) exchange in 2015.The cause of fracture was most likely lack of bony support of the shield, resulting in bending stress and, in case of adipositas permagna material fatigue.The patient underwent a revision surgery on (b)(6) 2022.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components nr386k - enduro femur sp:acer post/dist f3 4x4mm - lot 52113336.Nr293k - femur extens.Stem 6° d18x77mm cemented - lot 52135389.Nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52135289.Nb013k - enduro tibial comp.Offset cemented t3 - lot 52159428.Nb067k - enduro tibia hemi-wedge t3 12mm rm/ll - lot 51760228.Nb075k - enduro tibia hemi-wedge t3 4mm rl/lm - lot 52107302.Nr193k - tibia offset stem d18x52mm cemented - lot 52137131.Nr890m - enduro meniscal component f3 10mm - lot 52161161.

• Brand Name: ENDURO FEMORAL COMPONENT CEMENTED F3R
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13559429
• Report Number: 9610612-2022-00028
• Device Sequence Number: 19874263
• Product Code: KRO
• UDI-Device Identifier: 04046963165574
• UDI-Public: 4046963165574
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: NB019K
• Device Catalogue Number: NB019K
• Device Lot Number: 52161077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NB013K - LOT 52159428; NB067K - LOT 51760228; NB075K - LOT 52107302; NR193K - LOT 52137131; NR293K - LOT 52135389; NR386K - LOT 52113336; NR400K - LOT 52135289; NR890M - LOT 52161161
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 133 KG