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

Model Number	NX055Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2022
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 nx055z - as vega ps tibial plateau cemented t3 that was initially implanted during a left total knee arthroplasty (tka) procedure performed on (b)(6) 2013.According to the complaint description, the aseptic loosening of aesculap vega cemented total knee replacement with-de-bonding of the implant from the cement mantle.A revision surgery was necessary.The adverse even is filed under aag reference 100032170 (400582826).Associated medwatch-reports: 400582827 (9610612-2022-00391) - nx013z, 400582826 (9610612-2022-00390) - nx055z.Involved components: 400582824 - nn260p - plug f/tibial plateau - lot 51917990, 400582825 - nx044 - patella 3-pegs p4 - lot 51849212, 400582828 - nx131 - vega ps gliding surface t3/3+ 12mm - lot 51872457.
Additional Manufacturer Narrative
Investigation: an investigation method could not be applied, because products were not provided to us for investigation.No products at hand, therefore a failure description of the product is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for this product and found to be according to our specification valid at the time of production.There are 3 similar complaints against the same lot number.Explanation, rationale, conclusion and root cause: on the basis of the current information and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Based on the investigation results, a capa is not required.
Event or Problem Description
The adverse even is filed under aag reference (b)(4),((b)(6)).Associated medwatch-reports: (b)(6) (9610612-2022-00391) - nx013z, (b)(6) (9610612-2022-00390) - nx055z.Involved components: (b)(6)- nn260p - plug f/tibial plateau - lot 51917990, (b)(6)- nx044 - patella 3-pegs p4 - lot 51849212, (b)(6)- nx131 - vega ps gliding surface t3/3+ 12mm - lot 51872457.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T3
• 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: 16199759
• Report Number: 9610612-2022-00390
• Device Sequence Number: 5971784
• Product Code: JWH
• UDI-Device Identifier: 04046963810450
• UDI-Public: 4046963810450
• 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: 2022
• 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): 02/10/2023

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: 08/31/2017
• Device Model Number: NX055Z
• Device Catalogue Number: NX055Z
• Device Lot Number: 51873261
• 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: 01/13/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 51917990; NN260P - LOT 51917990; NX044 - LOT 51849212; NX044 - LOT 51849212; NX131 - LOT 51872457; NX131 - LOT 51872457
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male