MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T1+; KNEE ENDOPROSTHESES

Model Number	NX052Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/14/2021
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 nx052z - as vega ps tibial plateau cemented t1+.According to the complaint description, patient underwent revision surgery 1 year 10 months post surgery due to loosening of tibia implant.Initial surgery: (b)(6) 2018.Revision surgery: (b)(6) 2021.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: nn261z - as tibial obturator d12mm - lot 52393406.Nx110 - vega ps gliding surface t1/1+ 10mm - lot 52396660.Nx009z - as vega ps femoral comp.Cemented f4n l - lot 52357510.
Additional Manufacturer Narrative
Investigation results/ visual investigation: the provided components were examined visually and microscopically with the digital microscope and the digital-camera.The complained tibial component shows no bone cement residues adhesive on the intended area.The also provided femoral component shows nearly no bone cement residues on the intended area.There are no obvious visible material/coating defects on the provided devices.The provided gliding surface of the meniscal component shows visible scratches and imprints resulted from third body wear (bone cement residues and/or bone chips).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 x probability of occurrence) 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.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T1+
• 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: 12618323
• Report Number: 9610612-2021-00691
• Device Sequence Number: 16481019
• Product Code: JWH
• UDI-Device Identifier: 04046963810399
• UDI-Public: 4046963810399
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 12/28/2021

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 Expiration Date: 10/31/2024
• Device Model Number: NX052Z
• Device Catalogue Number: NX052Z
• Device Lot Number: 52094456
• 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: 04/14/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2014
• 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: NN261Z - LOT 52393406; NX009Z - LOT 52357510; NX110 - LOT 52396660; NN261Z - LOT 52393406; NX009Z - LOT 52357510; NX110 - LOT 52396660
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown