MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP FEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	V0100107
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Injury (2348); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka surgery, the femur cutting guide vis adpt guide lgnp fem did not make contact with the femur anterior hook or with distal.The surgeon had to change surgical technique and switched to standard instruments.The procedure finished with a surgical delay of less than 30 minutes and no injury to the patient.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the visionaire¿ femur cutting guide ¿did not make contact with the femur anterior hook or with distal¿.Reportedly, the surgeon ¿switched to standard instruments¿ to conclude the procedure within a 0-30 minute surgical extension and the ¿patient was not harmed¿.Responses to information requests were not provided.Based on the limited information, the root cause of the reported event could not be concluded.Patient impact beyond the modified surgical technique and 0-30 minute surgical delay is not anticipated as there was no patient harm/injury per complaint.No further medical assessment is warranted at this time.Should additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Additional information: d3, g1 and g4.

• Brand Name: VIS ADPT GUIDE LGNP FEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10292542
• Report Number: 1020279-2020-03313
• Device Sequence Number: 10963600
• Product Code: JWH
• UDI-Device Identifier: 00885556656372
• UDI-Public: 00885556656372
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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: V0100107
• Device Catalogue Number: V0100107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention