MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F2 12MM; KNEE ENDOPROSTHESES

Model Number NR881M

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 08/07/2021

Event Type  Injury  

Event Description

It was reported to aesculap ag that an enduro meniscal component f2 12mm (part # nr881m) was implanted during a primary procedure performed approximately in 2015.According to the complainant, the patient was originally implanted with a bilaterally outward fitted axis-coupled k-tep enduro.Reportedly, the axis fractured two (2) years post surgery.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00638 ((b)(4)).9610612-2021-00717 ((b)(4)).Involved components nb018k - enduro femoral component cemented f2r - lot 52079897.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.This device was additionally added to the intial complaint of this case filed under mdr id #: 9610612-2021-00638.

Manufacturer Narrative

Investigation results: visual investigation: the rotation axis (nr873201) has fractured above the taper, directly below the screw thread.The components were examined visually and microscopically.The taper of the rotation axis shows less 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.The hinge ring (nb014203) shows clearly signs of a hyperextension.The meniscal component (nr881200) exhibits no abnormal damages.We found a small number of fixed metal chips on the gliding surface of the meniscal component.The locking ring (nr873202) and the bearing for rotation axis (nr873203) 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.

Event Description

Correction: added involved component - nr860k changed from leading material to involved component after investigation.Associated medwatch-reports: 9610612-2021-00638 (400527610 + nr860k).9610612-2021-00717 (400532704 + nr881m).Involved components: nb018k - enduro femoral component cemented f2r - lot: 52079897.Nr860k - enduro locking nut f/rotation axis - lot: 52291905.

• Brand Name: ENDURO MENISCAL COMPONENT F2 12MM
• 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: 12796514
• MDR Text Key: 280815158
• Report Number: 9610612-2021-00717
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04046964010293
• UDI-Public: 4046964010293
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: NR881M
• Device Catalogue Number: NR881M
• Device Lot Number: 52250489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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
• Treatment: NB018K - LOT 52079897.; NB018K.; NR860K - LOT 52291905.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female