MAUDE Adverse Event Report: SMITH AND NEPHEW INC VISIONAIRE LT CUTTING BLOCK KIT - LGNP; PROSTHESIS,KNEE,PATELLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	V0100022
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the block bailed on femur 5-10 degrees too much internal rotation, used sizer and dropped to a 6.Dropped from 8 to 6 on tibia too.Plan was changed and alignment was changed prior to making bone cuts.
Additional Manufacturer Narrative
The associated visionaire cutting block 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.Our investigation including an engineering evaluation by our visionaire team noted that the tibia was oversized.The tibia was planned such that the tibial baseplate was sitting on an osteophyte.Tibia should have been downsized to ensure it was sitting fully on healthy bone.Root cause could not be found for the rotational and size issues with the femur described in the complaint.A clinical evaluation noted that he reported change in procedure, alignment, and reduction of the femoral and tibia sizes to a 6 prior to making bone cuts was congruent with the visionaire post-op evaluation summary.Patient impact beyond the expected post-op convalescence period is unlikely based on the reported successful outcome of the procedure which is in line with the technique to convert to traditional instrumentation as necessary.No further medical assessment is warranted at this time.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 LT CUTTING BLOCK KIT - LGNP
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7672002
• Report Number: 1020279-2018-01277
• Device Sequence Number: 1018537
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/20/2018

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: Health Professional
• Device Catalogue Number: V0100022
• Device Lot Number: 00113348
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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: Other