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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); Pain (1994); Deformity/ Disfigurement (2360); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
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, the knee of the patient ended up in 10 degrees of valgus.According to surgeon, both blocks from ns visionaire adaptive guide kit journey ii fit well during the procedure.The tibia alignment rod was used to place block.The cuts were made.Once the implants were cemented, the surgeon used alignment rods to measure and noticed that the knee was in valgus.The patient current status is unknown.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: given the nature of the alleged incident, the device, could not be returned for evaluation.This issue was evaluated through our internal quality process and determined the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported ¿knee of the patient ended up in 10 degrees of valgus,¿ cannot be confirmed based on the analysis of the x-rays and the single intraop image provided.The engineering evaluation revealed findings were inside acceptance criteria.Per the office note, the 01-04-22 x-rays show ¿a right tk prosthesis well aligned, intact with no evidence of loosening¿ or tissue/bony abnormalities and was not identified in the operative report.It was communicated that although the surgeon was not satisfied with the outcome ¿initially¿ in the or, the surgeon was satisfied ¿after seeing him in clinic¿.The patient impact beyond the reported ¿patient ended up in 10 degrees of valgus¿, post-pain, effusion, and limp cannot be determined.It is unknown if any future interventions are planned or scheduled.No further 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 complaint history for the previous 24 months did not reveal similar events for the listed device.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 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.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.Corrected data: h6 (health effect - clinical code, health effect - impact code).

• 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: 13208756
• Report Number: 1020279-2022-00147
• Device Sequence Number: 14619371
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 00885556658406
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: V0200112
• Device Catalogue Number: V0200112
• Device Lot Number: 00220339
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 10/04/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown