MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE LT CUTTING BLOCK KIT-GII; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLYMER

Model Number	V0100012
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that revision surgery will be performed due to probable instability of the knee joint.In the primary surgery, a gii system was implanted on the right knee.During the medical consult, it was noticed the label for the visionaire instrument used was for a left knee, which may be causing the instability problem in the patient.It is uncertain if the devices were mislabeled or if a mistake was made at the time of the implantation.
Additional Manufacturer Narrative
Results of investigation: it was reported that surgery was recommended due to probable instability of the knee joint.In the primary surgery, a genesis ii system was implanted on the right knee.The affected genesis ii left visionaire cutting block, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Complaint history review did not identify any other similar incident.The engineering evaluation by our visionaire team noted that after evaluation, it was found that the case as well as the images were all booked as a left knee.If the implant was used on a right knee, as stated in the complaint, it is considered off label use.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Possible cause could include but not limited to user error.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: VISIONAIRE LT CUTTING BLOCK KIT-GII
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9449008
• Report Number: 1020279-2019-04373
• Device Sequence Number: 16916737
• Product Code: JWH
• UDI-Device Identifier: 03596010653116
• UDI-Public: 03596010653116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 12/08/2015
• Device Model Number: V0100012
• Device Catalogue Number: V0100012
• Device Lot Number: 00026393V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1