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

Catalog Number	V0100023
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Block did not fit patient anatomy.Block was thrown away by account.
Additional Manufacturer Narrative
Results of investigation: the associated visionaire cutting block 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.Our clinical evaluation noted that no clinical supporting documentation has been provided for inclusion in this investigation.Without the requested clinical information, a thorough clinical/medical investigation cannot be rendered.Our investigation including an engineering evaluation by our visionaire team noted that some errors occurred during the segmentation of this case.The block fit issue described in the complaint could have been cause by one or more of these errors.The alignment engineer along with the segmenter have taken steps to ensure that all surgeon preferences are met going forward.At this time we feel these actions will prevent recurrence of this failure.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.Should additional information be received, the complaint will be reopened.

• Brand Name: VISIONAIRE RT CUTTING BLOCK KIT - LGNP
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489380
• Report Number: 1020279-2018-00867
• Device Sequence Number: 10799349
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: Physician
• Device Catalogue Number: V0100023
• Device Lot Number: 00105988V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention