MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP FEM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	V0100107
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon attempted to place the femoral cutting block on the patient, he was having block fit issues.The block did not appear to match the anterior cortex of the patient's femoral bone anatomy.The surgeon did not use the cutting guide and went with standard instruments.No delays reported.No patient injuries reported.It is unknown if an s&n backup device was available.
Additional Manufacturer Narrative
It was reported that when the surgeon attempted to place the femoral cutting block on the patient, he was having block fit issues.The block did not appear to match the anterior cortex of the patient's femoral bone anatomy.The surgeon did not use the cutting guide and went with standard instruments.The associated legion visionaire adaptive guide kit was not returned for evaluation.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No prior complaints for this part as this is a patient specific device.Our investigation including an engineering evaluation by our visionaire team found that the anterior tip of the femur osteophyte was undersegmented throughout, explaining the anatomy indifference noticed by surgeon.The root cause is incorrect segmentation.A relationship between the device and the reported incident or adverse event is corroborated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.Credit cannot be issued for this device.

• Brand Name: VIS ADPT GUIDE LGNP FEM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8834206
• Report Number: 1020279-2019-02781
• Device Sequence Number: 2742955
• Product Code: JWH
• UDI-Device Identifier: 00885556656372
• UDI-Public: 00885556656372
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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 Catalogue Number: V0100107
• Device Lot Number: 00146261V1
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR