MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F2R; KNEE ENDOPROSTHETICS

Model Number	NB018Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an as enduro femoral component cemented f2r (nb018z) was implanted during a total knee arthroplasty (tka) procedure performed on (b)(6) 2020.According to the complaint description, the femur became loose.The patient underwent a revision procedure on (b)(6) 2023.And the doctor revised the femur.This incident occured post-operative.A revision surgery was necessary.No patient complications were reported as a result of the revision procedure.The adverse event is filed under aag reference (b)(4).Involved components: nr410z - as femur extens.Stem 5° d20x117 cem.Less - lot 52455976.Nr592z - as enduro fem.Spacer post/dist f2 12x4mm - lot 52325498.Nr882z - as enduro meniscal component f2 14mm - lot 52559347.Nx045 - patella 3-pegs p5 - lot 52431745.Nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52569541.
Event or Problem Description
Involved components: nr410z - as femur extens.Stem 5° d20x117 cem.Less - lot 52455976 nr592z - as enduro fem.Spacer post/dist f2 12x4mm - lot 52325498 nr882z - as enduro meniscal component f2 14mm - lot 52559347 nx045 - patella 3-pegs p5 - lot 52431745 nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52569541.
Additional Manufacturer Narrative
Additional information: h6 - codes updated.Investigation: an investigation method could not be applied, because a device/explant was not provided for investigation.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are 0 similar complaints against the same lot number.Conclusion/preventive measures: in the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine the root cause for the mentioned loosening of the implant.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Based upon investigation results, a capa is not necessary.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F2R
• Common Device Name: KNEE ENDOPROSTHETICS
• 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: 17073262
• Report Number: 9610612-2023-00139
• Device Sequence Number: 17814646
• Product Code: KRO
• UDI-Device Identifier: 04046963177546
• UDI-Public: 4046963177546
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2023

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: 11/20/2024
• Device Model Number: NB018Z
• Device Catalogue Number: NB018Z
• Device Lot Number: 52570629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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: NR400Z - LOT 52569541; NR400Z - LOT 52569541; NR410Z - LOT 52455976; NR410Z - LOT 52455976; NR592Z - LOT 52325498; NR592Z - LOT 52325498; NR882Z - LOT 52559347; NR882Z - LOT 52559347; NX045 - LOT 52431745; NX045 - LOT 52431745
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male