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

Model Number	V0200109
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, a cutting block from a visionaire adaptive guide kit legion primary did not fit perfectly.It was poorly supported in the antero-internal area, or if this one was well supported, the block did not fit distally to the condyles.The best possible fit resulted in pin placement with too much external rotation.After the distal cut was performed, it was immediately obvious that something was wrong.It is unknown if this issue caused any surgical delay; however, the procedure was completed with the same device.The current health status of patient is unknown.
Event or Problem Description
It was reported that, during a tka surgery, a cutting block from a visionaire adaptive guide kit legion primary did not fit perfectly.It was poorly supported in the antero-internal area, or if this one was well supported, the block did not fit distally to the condyles.The best possible fit resulted in pin placement with too much external rotation.After the distal cut was performed, it was immediately obvious that something was wrong on the rotation of the femur cutting block.The procedure was completed with a non-significant delay, using the same device.However, the surgeon had to re-align with conventional instruments, and a third pin had to be used.The current health status of patient is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and they confirm that the device did not fit as intended in the patient.The clinical/medical investigation concluded that, without the requested clinically relevant information, the root cause of the reported ¿cutting block did not fit perfectly¿ cannot be definitively concluded.The patient impact beyond the reported events cannot be determined and the patient¿s current health status remains unknown.The surgery was reportedly completed with the same device with a 0-30-minute surgical extension, and then re-aligned with conventional instruments and a third pin used.No further medical assessment can be rendered.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.An engineering evaluation was performed and determined that a probable root cause for the reported event could be failure to segment correctly the femur.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, user/procedural variance or segmentation errors.The contribution of the device to the reported event could be corroborated since it didn't perform as expected and the surgeon had to re-align with conventional instruments.This issue was evaluated through our internal quality process and based on a risk assessment, determined that the need for corrective actions 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.Internal complaint reference number: (b)(4).

• Brand Name: NS VIS ADPT GUIDE LGNP KIT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 13142410
• Report Number: 1020279-2022-00011
• Device Sequence Number: 4651714
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: 00218746V1
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 01/03/2022; 07/12/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/04/2022; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female