MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T2; KNEE ENDOPROSTHESES

Model Number	NX053Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: up until this time, the product has not been returned.Therefore, a complete investigation could not be performed.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and 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.If the product is returned at a later date, the investigation will again be completed.Regarding (vega) implant loosening, product safety cases (pscs) were initiated.
Event or Problem Description
It was reported to aeculap ag that an as vega ps tibial plateau cemented t2 (part # nx053z) was implanted during a primary procedure performed in 2018.According to the complainant, there was postoperative loosening of the implant.This occurred due to a patient fall.The patient underwent a revision procedure on (b)(6) 2022.The complaint device has not been returned to the manufacturer for evaluation.A revision was required; columbus revision products were implanted.Further details have been requested.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch report: (b)(4) (9610612-2022-00280) nx029z.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T2
• Common Device Name: KNEE ENDOPROSTHESES
• 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: 15539928
• Report Number: 9610612-2022-00281
• Device Sequence Number: 17910801
• Product Code: JWH
• UDI-Device Identifier: 04046963810412
• UDI-Public: 4046963810412
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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 Model Number: NX053Z
• Device Catalogue Number: NX053Z
• 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: 09/09/2022
• Initial Report FDA Received Date: 10/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown