MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F3 12MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	NR891M
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 enduro meniscal component f3 12mm (part # nr891m) was used during a procedure performed on an unknown date.According to the complainant, the enduro uncoupled with locking nut and was lying freely in the joint.The patient underwent a revision procedure on an unknown date.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision surgery.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Event or Problem Description
Correction: nr891m - enduro meniscal component f3 12mm.Was changed from leading material to involved component.Associated medwatch-reports: 9610612-2021-00813 (400531692 - nb019k) 9610612-2021-00676 (400530846 - nr891m).
Additional Manufacturer Narrative
Correction/additional information - block b5, h6 (component code) based upon investigation results, this event was re-evaluated and is considered no longer reportable due to the change from being leading material to involved component.All information regrarding this case will be reported in 9610612-2021-00813 (400531692 - nb019k) investigation results: visual investigation: the external screw thread of the rotation axis shows visible damages/ material abrasions on the whole circumference.The components have been examined visually and microscopically.The external screw thread of the rotation axis shows visible damages/ material abrasions on the whole circumference.The inner thread of the rotation axis locknut shows no visible damages.There are visible imprints on the taper of the rotation axis.Furthermore there are little metal inclusions on the gliding surface as well as on the bottom side of the meniscal component.The locking ring and the bearing for rotation axis show no significant/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 (b)(6) 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 F3 12MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 12711948
• Report Number: 9610612-2021-00676
• Device Sequence Number: 14575043
• Product Code: KRO
• UDI-Device Identifier: 04046964010446
• UDI-Public: 4046964010446
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 10/31/2019
• Device Model Number: NR891M
• Device Catalogue Number: NR891M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2014
• 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: NR891M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male