MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T4; KNEE ENDOPROSTHESES

Model Number	NX057Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
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.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 for vega loosening a product safety case (psc) was initiated (zs-notification: (b)(4)) and psc 2021-059 - vega - loosening of implant.
Event or Problem Description
It was reported to aesculap inc.That an as vega ps tibial plateau cemented t4 (part # nx057z) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, post-operation early loosening of knee tep implant.The patient underwent a revision procedure on (b)(6) 2022.The complaint device has not been returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components: nx140 - vega ps gliding surface t4/4+ 10mm - lot 52437122.Nx014z - as vega ps femoral comp.Cemented f6l - lot 52344340.
Event or Problem Description
Associated medwatch-reports: 9610612-2022-00077 (400545223 - nx014z); 9610612-2022-00051 (400545222 - nx057z).Involved components: nx140 - vega ps gliding surface t4/4+ 10mm - lot 52437122.
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.Several x-rays were later provided.According to the surgical report provided, there was no connection/adhesive between bone cement and implant.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 (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: it could be possible that there were problems with the cement technique and due to this the implant has loosened prematurely.The provided x-ray figure give no clear hints regarding the root cause for the implant loosening.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 for vega loosening a product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T4
• Common Device Name: 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: 13699411
• Report Number: 9610612-2022-00051
• Device Sequence Number: 20423705
• Product Code: JWH
• UDI-Device Identifier: 04046963810498
• UDI-Public: 4046963810498
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: NX057Z
• Device Catalogue Number: NX057Z
• Device Lot Number: 52385796
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2017
• 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: NX014Z - LOT 52344340; NX140 - LOT 52437122; NX140 - VEGA PS GLIDING SURFACE T4/4+ 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 105 KG