MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMPSZ 6 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420026
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
At the moment of opening the implants, inside the femur box, which had a description of size 6 r, c-r, of chromium cobalt genesis ii, we found an implant of size 4 left c-r of chromium cobalt genesis ii, even with a 6r c-r sticker.After the frustration of the surgeon and the incomprehension of the medical team, and not having how to solve the problem quickly due to the distance with the warehouse and the anesthetized patient, it was decided to open other femur implant size 5 r, chromium cobalt genesis ii, and after, it was physically checked due to the previous issue.The femur was worked with blocks of size 5, and finally it was placed an implant 5 r, cr, crco genesis ii, modifying the size of the patient's femur.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.However, our investigation indicated that the related failure was part of field action initiated in 2018.Corrective actions have been initiated.Our clinical evaluation noted that no current report on how the patient tolerated the procedure was provided and future impact resulting from the altered size of implant is unknown.No additional actions are being taken at this time.If additional information is received in the future, this complaint will be reopened.We consider this investigation closed.Credit cannot be issued for the device.

• Brand Name: GEN II COCR CR NP FEMORAL COMPSZ 6 RIGHT
• 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: 7590262
• Report Number: 1020279-2018-01104
• Device Sequence Number: 1698350
• Product Code: JWH
• UDI-Device Identifier: 03596010205568
• UDI-Public: 03596010205568
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 71420026
• Device Lot Number: 16CMB0064A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1