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

Model Number NR880M

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/28/2022

Event Type  Injury  

Event Description

It was reported to aesculap aag that an enduro meniscal component f2 10mm (part # nr880m) was implanted during a primary procedure performed on (b)(6), 2016.According to the complainant, following a patient trauma, the device experienced an axle fracture.The patient underwent a revision surgery on (b)(6), 2022.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation: the components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".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 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 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 gliding surface of the meniscal component (nr880200) shows visible scratches, imprints and little deformations.Furthermore we found a small number of fixed metal chips on the gliding surface of the meniscal component.The locking ring (nr872202) and the bearing for rotation axis (nr872203) show no unusual damages.Batch history review: the device quality and manufacturing history records (dhr) 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 no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (4(5)severity x 2(5)probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale/conclusion and root cause: according to the quality standard and dhr files a material defect and production error was not found.There are no hints for a material or manufacturing problem.The fracture surface exhibit no material defects like foreign particles inclusions or blow holes.On the basis of the current information, without more detailed information about the patient and the prevailing circumstances a clear conclusion cannot be drawn.The visible damages/material abrasions on the taper of the rotation axis could be an indication that the hinge connection of the femur has been moving on the taper.A reason for this could be that the rotation axis locking nut has come loose a little bit, respectively was not firmly fitted.The load transfer in this case is transmitted through the narrowest part of the axis and not through the main axis.Furthermore it could be possible that a special patient situation, for example: - disturbance in coordination - underlying disease - missing muscular guidance of the leg - hyperextension led to extreme and unusual bending moments and in the end to the breakage of the axis at the narrowest part.Furthermore a patient trauma is mentioned under point previously.All these factors could have contributed to the breakage.Corrective action: a capa is not necessary.

• Brand Name: ENDURO MENISCAL COMPONENT F2 10MM
• Type of Device: 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: 13599497
• MDR Text Key: 290085655
• Report Number: 9610612-2022-00007
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04046964010286
• UDI-Public: 4046964010286
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: NR880M
• Device Catalogue Number: NR880M
• Device Lot Number: 52199743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male