MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	71420164
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a left tibial baseplate and left femoral component were implanted in the patient's right knee.This was noticed in post-op xray.Patient elected not to go back to surgery.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, as this complaint is being handled through smith & nephew's legal team, any responses to these queries are not immediately available to the members of smith nephew's complaint/regulatory team and are not expected to be available for several months.This is due to the delivery timeframe of patient medical information and device return being in the control of the patient's legal team, rather than s&n.The s&n legal team has confirmed that once any additional relevant complaint information is received, (i.E.Reason for complaint, part/lot numbers, patient medical records, surgeon, device availability, and dates of implantation/revision) it will be provided to the complaint/regulatory team, at which point the complaint and or medical investigation task will be reopened for investigation.Therefore, a clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8742157
• Report Number: 1020279-2019-02493
• Device Sequence Number: 14112849
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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 Expiration Date: 10/18/2018
• Device Catalogue Number: 71420164
• Device Lot Number: H1818450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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