MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 1 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420160
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka procedure, the surgeon decided to implant journey ii, and procedure was completed.When chart-stick label was checked 2days later, it was found that incorrect base plate was implanted to the patient.It mean that journey ii bcs femoral component, journey ii bcs insert and genesis ii base plate were implanted to the patient.The incorrect product (combination) was implanted.(journey ii insert was implanted to the genesis ii base plate).
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and this case reports a user/procedural error occurred when the surgeon opened the incorrect implant during a tka. it was also reported there was no delay in the harm to the patient. no revision has been scheduled as of now; however, the surgeon plans to keep following the patient. without the relevant clinical documents neither, the risk or the impact to the patient as a result of the incorrect product implantation cannot be concluded. no further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 1 LEFT
• 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: 7824750
• Report Number: 1020279-2018-01654
• Device Sequence Number: 2348001
• Product Code: JWH
• UDI-Device Identifier: 03596010206237
• UDI-Public: 03596010206237
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 71420160
• Device Lot Number: 18CM12727
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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