MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F6N R; KNEE ENDOPROSTHETICS

Model Number	NX033Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that there was an issue with nx033z - as vega ps femoral comp.C.According to the complaint description, there was a gross loosening of the femoral and tibial components of the right knee.The patellar component was well fixed.A revision surgery was necessary.Additional information was not provided.The adverse event is filed under aag reference 100032169 (400582821).Associated medwatch-reports: 400582818 (9610612-2022-00392) - nx055z, 400582821 (9610612-2022-00393) - nx033z.Involved components: 400582819 - nx044 - patella 3-pegs p4 lot 51849212, 400582820 - nx132 - vega ps gliding surface t3/3+ 14mm - lot 51901306, 400582822 - nn260p - plug f/tibial plateau - lot 51910799.
Additional Manufacturer Narrative
Investigation: because we did not receive any sample, a thorough investigation was not possible.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 3 similar complaints against the same lot number 51873261 (including this complaint).The current failure rate is within the risk analysis and therefore acceptable.Conclusion and preventive measures: on the basis of the current information a clear conclusion regarding the root cause cannot be drawn.At this time there are no hints for a product related error; if products are returned in the future, another investigation will be performed unsolicited.Based upon the investigation results, a capa is not necessary.
Event or Problem Description
Associated medwatch-reports: 400582818 (9610612-2022-00392) - nx055z, 400582821 (9610612-2022-00393) - nx033z.Involved components: 400582819 - nx044 - patella 3-pegs p4 lot 51849212.400582820 - nx132 - vega ps gliding surface t3/3+ 14mm - lot 51901306.400582822 - nn260p - plug f/tibial plateau - lot 51910799.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F6N 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16198981
• Report Number: 9610612-2022-00393
• Device Sequence Number: 5971222
• Product Code: JWH
• UDI-Device Identifier: 04046963810207
• UDI-Public: 4046963810207
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 09/30/2022
• Device Model Number: NX033Z
• Device Catalogue Number: NX033Z
• Device Lot Number: 51888840
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2012
• 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: NN260P - LOT 51910799; NN260P - LOT 51910799; NX044 - LOT 51849212; NX044 - LOT 51849212; NX132 - LOT 51901306; NX132 - LOT 51901306
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown