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

Model Number	V0200112
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a tka performed on an unknown date, the alignment provided by the (b)(6).Jii kit was not optimal.The surgeon felt like the anterior flange of the implant diverted off the anterior femur, but decided to go through the procedure anyway.The procedure was successfully completed using the same device.The patient will not need an additional intervention.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could be confirmed.The engineering evaluation performed revealed that the femoral alignment planned did not have the femoral component anterior flange make full contact with the resected femur.The clinical/medical investigation concluded that, the provided x-ray was reviewed and appears to support the complaint, however, it does not provide insight into the root cause of the reported event.The engineering evaluation revealed ¿due to the shape of the anterior cortex of the patient, if the alignment engineer had not added flexion to the femur or had not shifted the component anteriorly, the planned anterior resection would have appeared to notch the anterior cortex.¿ additionally, per the engineering evaluation, the plan was auto approved (¿pre-op plan auto-approved after the 48 hour window expired¿) and the projected alignment is consistent with what was captured in the post tka x-ray.The patient impact beyond the reported ¿implant diverted off the anterior femur¿ would not be anticipated.No patient harm has been alleged.Reportedly the procedure was ¿successfully completed using the same device,¿ and ¿the patient will not need an additional intervention.¿ the patient¿s current health was not provided.Therefore, no further clinical medical assessment can 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 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.At this time, we have reason to suspect that the product failed to meet any product specifications at the time of manufacture.As the femoral alignment planned did not have the femoral component anterior flange make full contact with the resected femur, no probable cause is deemed necessary.The contribution of the device to the reported event could be corroborated as the as the x-rays confirm the alignment of the device is not optimal.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: NS VIS ADPT GUIDE JII KIT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 13515712
• Report Number: 1020279-2022-00660
• Device Sequence Number: 5299283
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 00885556658406
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 04/03/2022
• Device Model Number: V0200112
• Device Catalogue Number: V0200112
• Device Lot Number: 00222808V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 08/24/2022
• Date Device Manufactured: 10/05/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown