MAUDE Adverse Event Report: AESCULAP AG VEGA PS FEMORAL COMPONENT CEMENTED F5N R; KNEE ENDOPROSTHETICS

Model Number	NX031K
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2021
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 nx031k-vega ps femoral component cemented f5n r.According to the complaint description, it was reported that an revision surgery was necessary due to cement had no tight bond with the implant.Additional information was provided on 19th of october.Reportedly, the cement used was optipac 40, refobacin plus.The adverse event / malfunction is filed under (b)(4).Involved components: nn261k-tibial obturator d12 mm-52522748 nx220-vega ps+ gliding surface t2/2+ 10mm-52516314 nn473k-columbus cra/psa tib.Plat.Cemented t2-52537882.
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: VEGA PS FEMORAL COMPONENT CEMENTED F5N 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: 12761930
• Report Number: 9610612-2021-00701
• Device Sequence Number: 14288662
• Product Code: JWH
• UDI-Device Identifier: 04046963810153
• UDI-Public: 4046963810153
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 12/17/2021

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: NX031K
• Device Catalogue Number: NX031K
• Device Lot Number: 52502712
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2019
• 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: NN261K-52522748; NN473K-52537882; NX220-52516314
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 85 KG