MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PRSTHSIS,KNEE,PATLLFMROTIBL,SMI-CNSTRAIND,CEMENTED,POLYMER/METAL/POLYMER

Catalog Number	71420168
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed since the implants moved position from primary surgery.The genesis ii size 5 tibia and 5/6 9mm insert were removed and replaced.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• Common Device Name: PRSTHSIS,KNEE,PATLLFMROTIBL,SMI-CNSTRAIND,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8123249
• Report Number: 1020279-2018-02650
• Device Sequence Number: 16560196
• Product Code: JWH
• UDI-Device Identifier: 03596010206275
• UDI-Public: 03596010206275
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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 Catalogue Number: 71420168
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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
• Patient Age: 68 YR