MAUDE Adverse Event Report: AESCULAP AG VEGA PS GLIDING SURFACE T5 10MM; GLIDING SURFACES/PATELLAS VEGA

Model Number	NX150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/09/2021
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 to aesculap ag that a vega ps gliding surface t5 10mm (part # nx150) was implanted during a procedure performed on (b)(6) 2014.According to the complainant, the inlay pin fractured.The patient underwent a revision procedure (b)(6) 2021.The complaint device was 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).Involved components: nx059k - vega ps tibial plateau cemented t5 -lot 52005866.Nn264k - tibial obturator d14mm - lot 52014474.Nx016k - vega ps femoral component cemented f7l - lot 52004743.
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried out visually and microscopically.The notch/post of the meniscal component was broken.The fracture surfaces of both parts (major part, minor part) have been analyzed microscopically.Both fracture surfaces exhibit so called arrest lines.The fracture surfaces show no material defects such as irregularities in the material structure or foreign material inclusions of any kind.Furthermore, this case was discussed with a specialist from the product management.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers 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 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard and dhr files a material defect and production error was not found.There are no hints for a material problem.We also exclude a design related error because the marked feedback regarding this failure is unremarkable.Despite material investigation and review of the patient's x-ray, no clear root cause for the fracture of the post can be identified.The provided x- rays give no clearly hints regarding the root cause for the fracture.The mentioned arrest lines arrest indicate a fatigue fracture.Therefore it can be assumed that the notch/post was loaded several times by the femoral component to such an extent that it ultimately led to its fracture.This most likely has a clinical/possibly also a patient-related root cause.It is possible that the patient developed a neurological gait disorder with an unusually, for example, strong hyperextension, which could have affected the notch/post.Furthermore it could be possible that due to high stress due to movement, caused by sports such as skiing or playing football, the implant was stressed over time to such an extent that it finally failed, respective contribute a fracture.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably patient- related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: VEGA PS GLIDING SURFACE T5 10MM
• Common Device Name: GLIDING SURFACES/PATELLAS VEGA
• 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: 12912817
• Report Number: 9610612-2021-00752
• Device Sequence Number: 17348517
• Product Code: JWH
• UDI-Device Identifier: 04046963811006
• UDI-Public: 4046963811006
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 12/01/2018
• Device Model Number: NX150
• Device Catalogue Number: NX150
• Device Lot Number: 51994345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2014
• 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: NN264K.; NX016K.; NX059K.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown