MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T3; KNEE ENDOPROSTHESES

Model Number	NX055Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2021
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 nx055z - as vega ps tibial plateau cemented t3.According to the complaint description, the implant loosened post surgery.A patient's right total knee was being revised for a loose tibial component.Upon exposure it was determined that both the femur & tibial component had debonded from the bone cement on both components.A temporary spacer was inserted until it could be determined that this joint was not infected.The patient is currently scheduled for re-implantation of his right knee on (b)(6) 2021.A revision surgery was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: nx031z - as vega ps femoral comp.Cemented f5n r - lot 52360163.
Event or Problem Description
Additional info received on aug 16,2021 that the revision surgery has moved to take place on (b)(6) 2021.Involved components: nx031z - as vega ps femoral comp.Cemented f5n r - lot: 52360163.
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.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 TIBIAL PLATEAU CEMENTED T3
• 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: 12282015
• Report Number: 9610612-2021-00574
• Device Sequence Number: 12113282
• Product Code: JWH
• UDI-Device Identifier: 04046963810450
• UDI-Public: 4046963810450
• 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): 12/16/2021

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: NX055Z
• Device Catalogue Number: NX055Z
• Device Lot Number: 52346878
• 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: 07/12/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• 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: NX031Z - AS VEGA PS FEMORAL COMP.CEMENTED F5N R.; NX031Z - AS VEGA PS FEMORAL COMP.CEMENTED F5N R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown