MAUDE Adverse Event Report: AESCULAP AG E.MOTION PS PRO MEN.COMP.F4/F4N L 10MM; KNEE ENDOPROSTHETICS

Model Number NX804

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information/investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with nx804-e.Motion ps pro men.Comp.F4/f4n l 10mm.According to the complaint description, specifically it was reported that dislocation of the implant has been occured.The revision surgery is scheduled for (b)(6).The additional information received on 2nd nov 2021 that there was no indication for any grounds as problems with the implant, physical appearance and function according to the surgeon.The adverse event/malfunction is filed under aag reference (b)(4).Associated medwatch reports: ((b)(4) nx804), 9610612-2021-00739 ((b)(4) nx904).

Manufacturer Narrative

Investigation results: visual investigation: the bottom side of both meniscal components shows visible damages.The provided components were examined visually and microscopically.Only on the bottom on both meniscal components there are visible scratches/imprints.The definitive origin of these several damages remains unclear.Probably these were created after the dislocation.The gliding surfaces are without any damages/signs of wear.There are no hints/signs of a product/material failure.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

Associated medwatch-reports: 9610612-2021-00724 (400533147 nx804); 9610612-2021-00739 (400534873 nx904).

• Brand Name: E.MOTION PS PRO MEN.COMP.F4/F4N L 10MM
• Type of Device: KNEE ENDOPROSTHETICS
• 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: 12805803
• MDR Text Key: 285063027
• Report Number: 9610612-2021-00724
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: NX804
• Device Catalogue Number: NX804
• Device Lot Number: 52407906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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