MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 14MM; KNEE ENDOPROSTHESES

Model Number	NR882M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that an enduro meniscal component f2 14mm (part # nr882m) was used during a procedure performed on (b)(6) 2018.According to the complainant, post operative fracture of implant due to broken coupling mechanism.The patient underwent a revision procedure on (b)(6) 2022.Intraoperatively, it was confirmed that the peg connecting the tibia and femur was broken.It could be replaced without any problems.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: nr400k - nut f/femur extens.Stem all sizes neutr.- lot 52431584; nx044 - patella 3-pegs p4 - lot 52120232; nb018k - enduro femoral component cemented f2r - lot 52438796; nb012k - enduro tibial comp.Offset cemented t2 - lot 52431525; nr175k - tibia offset stem d15x92mm cementless - lot 52324310; nr409k - femur extens.Stem 5° d19x117mm cem.Less - lot 51946677.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: visual investigation: the rotation axis (nr874201) has fractured above the taper, directly below the screw thread.The components were examined visually and microscopically with the digital microscope and the digital-camera.The taper of the rotation axis shows visible damages/imprints on the surface.The rotation axis locking nut (nr860k) is still fixed on the thread (broken part of the axis).The rotation axis locking nut is rotatable on the thread (broken part of the axis).The breakage surface of the larger distal part of the axis as well as the proximal fragment show signs of so called arrest lines which are typical for a dynamic fatigue fracture.Furthermore both parts (especially the larger distal part) exhibit partly secondary damages (shiny areas on the fracture surface), which were resulted due to rubbing against each other after the breakage.The fracture surfaces exhibit no material defects like foreign particles inclusions or blow holes.Unfortunately the hinge ring was not provided for investigation.Therefore it cannot be determined if hyperextension was present.The locking ring (nr874202) and the bearing for rotation axis (nr874203) show no unusual damages.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.

• Brand Name: ENDURO MENISCAL COMPONENT F2 14MM
• 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: 13663511
• Report Number: 9610612-2022-00054
• Device Sequence Number: 13939207
• Product Code: KRO
• UDI-Device Identifier: 04046964010309
• UDI-Public: 4046964010309
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 04/30/2023
• Device Model Number: NR882M
• Device Catalogue Number: NR882M
• Device Lot Number: 52433256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2018
• 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: NB012K - LOT 52431525; NB012K - LOT 52431525; NB018K - LOT 52438796; NB018K - LOT 52438796; NR175K - LOT 52324310; NR175K - LOT 52324310; NR400K - LOT 52431584; NR400K - LOT 52431584; NR409K - LOT 51946677; NR409K - LOT 51946677; NX044 - LOT 52120232; NX044 - LOT 52120232
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female