MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE RT CUTTING BLOCK KIT - LGNP; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENT, POLY/METAL/POLY

Catalog Number	V0100023
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the blocks did not fit.The surgeon didn´t use the blocks and changed the technic in order to complete the surgery.No delay was reported.
Additional Manufacturer Narrative
The associated legion visionaire cutting block kit was not returned for evaluation.Therefore a product evaluation could not be performed.However, case details have been provided.Therefore, an evaluation was conducted based on the information received.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including an engineering evaluation by our visionaire team noted that after evaluation, all upstream parameters were found to be within visionaire standards.No root cause could be determined for block fit complaint based on the limited information provided.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: VISIONAIRE RT CUTTING BLOCK KIT - LGNP
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8189768
• Report Number: 1020279-2018-02865
• Device Sequence Number: 11253039
• Product Code: JWH
• UDI-Device Identifier: 03596010653147
• UDI-Public: 03596010653147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: V0100023
• Device Lot Number: 00124729
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR