MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T1; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX051Z
Medical Device Problem Codes	Mechanical Problem (1384); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem Description
It was reported to aesculap inc.That an as vega ps tibial plateau cemented t1 device was implanted on (b)(6) 2012.According to the complainant, the patient experienced loosening of the as vega knee, which resulted in a revision surgery being performed on (b)(6) 2019.The cement used during the primary surgery is unknown.No known adverse patient effects occurred as a result of the revision surgery.The complaint device is not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nx027z - as vega ps femoral comp.Cemented f3n r - lot # unknown, nx042 - patella 3-pegs p2 - lot # unknown, nx051z - as vega ps tibial plateau cemented t1 - lot # unknown, nx100 - vega ps gliding surface t0/0+ 10mm - lot # unknown, nn260p - plug f/tibial plateau - lot # unknown.
Additional Manufacturer Narrative
Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The determination of a definite root cause is due to the non-availability of important information and the device itself not possible.The conclusion from the root cause analysis is that a systematic device deviation is unlikely since the received complaints are limited to certain health care institutions and their applicants.The participation of the applicants in this deviation scenario cannot be excluded by today.Based on the root cause analysis result no corrective actions have been carried out.As a preventive action we were in contact with the affected health care institutions and applicants in order to reduce the probability of recurrence.The complaints were submitted to aesculap ag as a summary report.In order to examine further actions, all cases from the summary report are processed as vigilance suspicion cases and are continuously monitored.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T1
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10535585
• Report Number: 9610612-2020-00488
• Device Sequence Number: 2803034
• 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: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: NX051Z
• Device Catalogue Number: NX051Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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: NN260P - PLUG F/TIBIAL PLATEAU.; NN260P - UNKNOWN.; NX027Z - AS VEGA PS FEMORAL COMP.CEMENTED F3N R.; NX027Z - UNKNOWN.; NX042 - PATELLA 3-PEGS P2.; NX042 - UNKNOWN.; NX100 - UNKNOWN.; NX100 - VEGA PS GLIDING SURFACE T0/0+ 10MM.; NN260P - PLUG F/TIBIAL PLATEAU; NX027Z - AS VEGA PS FEMORAL COMP.CEMENTED F3N R; NX042 - PATELLA 3-PEGS P2; NX100 - VEGA PS GLIDING SURFACE T0/0+ 10MM
• Outcome Attributed to Adverse Event: Required Intervention