MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F4N L; FEMUR IMPLANTS VEGA SYSTEM

Model Number	NX009Z
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number: e2014018.Manufacturing site evaluation: evaluation on-going.Device not returned.
Event or Problem Description
Country of complaint: usa.Received via medwatch (mw5075186): event description: tibial loosening, total knee replacement.Additional information has been requested.File will be updated when information is received.
Additional Manufacturer Narrative
Investigation: no product is at hand.Batch history review: the device quality and manufacturing history records have been checked for all lot numbers and found to be according to the specification, valid at the time of production.Similar incidents have been filed with products from batch 52259115 and 52259408.No similar incidents have been filed with products from the other batches.Conclusion and root cause: no product available, and therefore a complete analysis is not possible, but based on the information available, it appears the root cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage or patient related.Rational: according to the quality standard and dhr files, a material defect and production error can be excluded.Unfortunately due to a lack of data and without the product we can not determine the exact cause.Corrective action: product safety case 17-19.Any action regarding capa will be addressed with this case.
Event or Problem Description
Components in use listed as concomitant devices are: nx009z / as vega ps femoral comp cemented f4n l.Nx053z / as vega ps tibial plateau cemented t2.Nn261z / as tibial obturator d12mm.Nx122 / vega ps gliding surface t2/2+ 14mm.Nx042 / patella 3-pegs p2.
Additional Manufacturer Narrative
Additional information - b5, d1, d2, d4 (model #, lot #, exp.Date, udi), d10, g4 (pma/510(k)), h4.This report is being submitted retrospectively per fda request.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F4N L
• Common Device Name: FEMUR IMPLANTS VEGA SYSTEM
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7395689
• Report Number: 9610612-2018-00144
• Device Sequence Number: 11066737
• Product Code: JWH
• UDI-Device Identifier: 04046963809867
• UDI-Public: 4046963809867
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: NX009Z
• Device Catalogue Number: NX009Z
• Device Lot Number: 52273889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 04/06/2018; Not provided
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 09/01/2023; 08/27/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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: NN261Z / AS TIBIAL OBTURATOR D12MM; NX009Z / AS VEGA PS FEMORAL COMP.CEMENTED F4N L; NX042 / PATELLA 3-PEGS P2; NX053Z / AS VEGA PS TIBIAL PLATEAU CEMENTED T2; NX122 / VEGA PS GLIDING SURFACE T2/2+ 14MM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown