MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F4N R; KNEE ENDOPROSTHETICS

Model Number	NX029Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with nx029z - as vega ps femoral comp.Cemented f4n r.According to the complaint description, during explant of the primary knee components, the femur came right off and surgeon noticed that there was not much bone cement adhered to the femoral component.Only a couple of small patches of cement could be seen on the posterior condyles.No cement visible on any other part of component.All bone cement was only adhered to the bone on the femur.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: nx125 - vega ps gliding surface t2/2+ 20mm - lot unknown , nx053z - as vega ps tibial plateau cemented t2 - lot 52542951.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.It could be possible that there were problems with the cement technique and due to this no bone cement was adhered to the femoral component.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F4N R
• Common Device Name: 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: 12450636
• Report Number: 9610612-2021-00602
• Device Sequence Number: 12059783
• Product Code: JWH
• UDI-Device Identifier: 04046963810122
• UDI-Public: 4046963810122
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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 Model Number: NX029Z
• Device Catalogue Number: NX029Z
• Device Lot Number: 52452879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NX053Z - LOT 52542951; NX125 - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown