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

Model Number	V0100108
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during tka surgery, a vis adpt guide lgnp fem was down fitting well, but the alignment was very lateral.The procedure was completed using a s+n back-up device.Surgery was less than or equal to 30mins delayed.Patient was not harmed.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and the failure to align was confirmed.The clinical/medical investigation concluded that, the visionaire tibial block was ¿down fitting well, but the alignment was very lateral¿; therefore, the procedure was completed using a s+n back-up device within less than or equal to a 30mins surgical delay and ¿patient was not harmed¿.The provided intra-op image appears to support the complaint.Per the eqms case notes/correspondence, no further information is available.Reportedly, the engineering evaluation could not be performed without the batch number.Based on this limited information, the clinical root cause of the reported event could not be definitively concluded.The assessed patient impact was the reported lateral alignment which resulted in an unanticipated change in surgical technique and a 0-30 minute surgical delay.Reportedly the ¿patient was not harmed¿.No further patient impact would be anticipated.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.An engineering evaluation concluded that a root cause for the stated failure mode could not be confirmed.A historical review concluded that there are no prior actions related to this product and event.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, user/procedural variance or segmentation error.The contribution of the device to the reported event could be corroborated as the images confirm the very lateral alignment of the device.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 TIB
• 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: 12085972
• Report Number: 1020279-2021-05530
• Device Sequence Number: 14328368
• Product Code: JWH
• UDI-Device Identifier: 00885556656389
• UDI-Public: 00885556656389
• Combination Product (Y/N): N
• 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): 05/10/2022

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 Model Number: V0100108
• Device Catalogue Number: V0100109
• Device Lot Number: 00201891V1
• 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: 06/14/2021
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown