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

Model Number V0100112

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  Injury  

Event Description

It was reported that during a tka surgery, the visionaire femur block did not fit in the patient anatomy.Standard instruments were used to completed the femur procedure.It is unknown if there was a surgical delay.Additional complications were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the visionair femur block did not fit the patient¿s anatomy.Standard instrumentation was used to complete the procedure.No harm or impact to the patient was reported.Intra-operative pictures were provided for review, but did not add to the investigation.The impact to the patient cannot be determined because it is unknown if there was any surgical delay.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 was performed and did confirm a potential root cause for the stated failure mode.All checks were not found to be within visionaire standards.It was found that an osteophyte on the medial anterior femur was under segmented.A historical review concluded that there are no prior actions related to this product and event.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 error.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.

• Brand Name: VIS ADPT GUIDE KIT JII
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10155724
• MDR Text Key: 195223358
• Report Number: 1020279-2020-02408
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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
• Device Operator: Health Professional
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00171812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention