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

Model Number	NX051Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that an as vega ps tibial plateau cemented t1 (part # nx051z) was implanted during a left total knee arthroplasty (tka) procedure performed on (b)(6) 2013.According to the complainant, aseptic loosening of the femoral and tibial components was observed.The patella was noted as being in good position with no evidence of loosening.The patient underwent a revision surgery on (b)(6) 2021.The complaint device was not available to be returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: (b)(4) (9610612-2022-00389) - nx009z.Involved components: ((b)(4)) - nn260p - plug f/tibial plateau - lot 51959433.((b)(4)) - nx009z - as vega ps femoral comp.Cemented f4n l - lot 51944942.((b)(4)) - nx112 - vega ps gliding surface t1/1+ - lot 51946472.
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
Update: one of the involved components item number and name changed.(b)(6).The adverse event is filed under aag reference (b)(4) (b)(6).Associated medwatch-reports: (b)(6), (9610612-2022-00389) - nx009z.(b)(6), (9610612-2022-00388) - nx051z.Involved components: (b)(6) - nn260p - plug f/tibial plateau - lot 51959433.(b)(6) - nx042 - patella 3-pegs p2 - lot 51944942.(b)(6) - nx112 - vega ps gliding surface t1/1+ - lot 51946472.
Additional Manufacturer Narrative
Additional information - b5, d10, h6.Corrected information - d4 (exp.Date).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.No investigation method could be applied, because: no products were provided to us for investigation.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 there are 5 similar complaints against the same lot number.Explanation, rationale 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.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 T1
• 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: 16207435
• Report Number: 9610612-2022-00388
• Device Sequence Number: 5627683
• Product Code: JWH
• UDI-Device Identifier: 04046963810375
• UDI-Public: 4046963810375
• 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): 02/17/2023

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: 06/01/2023
• Device Model Number: NX051Z
• Device Catalogue Number: NX051Z
• Device Lot Number: 51957312
• 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: 01/19/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2012
• 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 51959433; NN260P - LOT 51959433; NX009Z - LOT 51944942; NX042 - LOT 51944942; NX112 - LOT 51946472; NX112 - LOT 51946472
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female