MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 10MM; KNEE ENDOPROSTHESES

Model Number	NR880M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: visual investigation: the components were examined visually and microscopically.The taper of the rotation axis shows small visible damage on the surface.The rotation axis locknut (nb014206) is no longer located/fixed on the thread of the rotation axis.The breakage surface of the proximal fragment shows so called arrest lines which are typical for a dynamic fatigue fracture.The breakage surface of the larger distal part of the rotation axis shows secondary damages (shiny surface).This indicates that the surface rubbed against another part after the breakage.The gliding surface of the meniscal component (nr880200) shows visible and noticeable scratches and imprints (wear marks) which were possibly caused by bone cement and/or bone chips.The locking ring (nr872202) and the bearing for rotation axis (nr872203) show no unusual damages the provided x-ray figures do not provide any explicit hints for the root cause of the rotation axis fracture.On the basis of the current information and as well as a result of our investigation, a definitive conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.There is no indication for a material defect or manufacturing failure.It could be possible that the fracture appears to have occurred due to a patient related recurring mechanical overload situation.In this context, the indicated body weight of >170kg could possibly play a significant role.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 meniscal component f2 10mm (part # nr880m) was implanted during a procedure performed on (b)(6) 2019 according to the complainant, two (2) years after the procedure, the axis of the device fractured.The patient underwent a revision procedure on an unknown date.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components nb015k - enduro femoral component cemented f2l - lot 52542132.

• Brand Name: ENDURO MENISCAL COMPONENT F2 10MM
• 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: 13809240
• Report Number: 9610612-2022-00069
• Device Sequence Number: 19949983
• Product Code: KRO
• UDI-Device Identifier: 04046964010286
• UDI-Public: 4046964010286
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 05/08/2024
• Device Model Number: NR880M
• Device Catalogue Number: NR880M
• Device Lot Number: 52521798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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: NB015K
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 170 KG