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

Model Number	NX054Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with nx054z as vega ps tibial plateau cemented t2+.The original implants had been a vega knee system, which later required tibia revision.This initial procedure occurred in (b)(6) 2017.It was noted that no cement adhered to the baseplate.The cement mantle was still complete on tibia.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under (b)(4).Involved components: nx221 - vega ps+ gliding surface t2/2+ 12mm, 52351863.Palacos r cement.
Additional Manufacturer Narrative
Investigation results: visual inspection : without a provided product, a investgation or visual inspection is not possible.Batch history review : the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures.Preventive measures: due to the lack of the information and without a product at hand a clear root cause could not be established.A product safety case was initiated.Notification number (700003390).

• 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
• MDR Report Key: 11031997
• Report Number: 9610612-2020-00889
• Device Sequence Number: 10960330
• Product Code: JWH
• UDI-Device Identifier: 04046963810436
• UDI-Public: 4046963810436
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: NX054Z
• Device Catalogue Number: NX054Z
• Device Lot Number: 52339503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NX221 - BATCH: 52351863
• Outcome Attributed to Adverse Event: Other