MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP KIT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL

Model Number	V0100109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka surgery, it was noticed that the vis adpt guide lgnp kit resulted in a varus tibia resection.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation but the reported event could be confirmed.According to the engineering evaluation, it was found that that the tibia alignment was left slightly varus from the patient's mechanical axis.The clinical/medical investigation concluded that, per complaint details, after a total knee arthroplasty surgery, it was noticed that the vis adpt guide lgnp kit resulted in a varus tibia resection.The provided electronic x-ray photo image was reviewed; however, due to the limited view, unable to confirm the varus alignment.Without the requested clinical documentation, the patient impact beyond the reported varus alignment could not be further assessed.No further medical assessment could be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting guide does not perform as intended, standard smith & nephew instrumentation should be used to complete the surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.An assessment made by a quality engineer was performed and did confirm a potential root cause for the stated failure mode.The evaluation found that the tibia alignment was left slightly varus from the patient's mechanical axis during the design process.Since this failure mode rate is within the anticipated acceptable risk limit in the risk management plan, no additional actions will be taken at this time.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Manufacturing process errors could be probable causes of the reported event.The contribution of the device to the reported event could be corroborated as the device was left slightly varus from the patient's mechanical axis and it resulted in a varus tibia resection.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: VIS ADPT GUIDE LGNP KIT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13078483
• Report Number: 1020279-2021-08822
• Device Sequence Number: 14522732
• Product Code: JWH
• UDI-Device Identifier: 00885556656396
• UDI-Public: 00885556656396
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: V0100109
• Device Catalogue Number: V0100109
• Device Lot Number: 00212579
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 09/05/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown