MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 LEFT; PROSTHSIS, KNEE,PTELLFEMOROTIBIAL,SMICONSTRAIND, CEMENTD,POLYMER/METAL

Catalog Number	71420166
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery has been performed due to a septic arthritis development.An incision and drainage with irrigation and debridement was performed on the left knee.
Additional Manufacturer Narrative
The affected genesis ii oval resurfacing patellar, legion non-porous femoral component, genesis ii tibial baseplate and genesis ii ps high flexion insert were not returned for evaluation.Our clinical analysis noted that no lab results or reports were provided to confirm the reported infection.However, the revision op report indicated there was some slimy granulation and synovium throughout the knee, this was debrided and all of the reported ¿infected tissue¿ was removed.Based on the limited information provided and without the return of the device for evaluation, there is no evidence to support our device contributed to the reported infection and as it was 2 years post op if it was infected it was likely a late hematogenously spread, therefore a thorough medical assessment cannot be completed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Products were sterilized according to sterilization release documentation from quality control.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GNS II CMT TIB SIZE 4 LEFT
• Common Device Name: PROSTHSIS, KNEE,PTELLFEMOROTIBIAL,SMICONSTRAIND, CEMENTD,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921366
• Report Number: 1020279-2018-01978
• Device Sequence Number: 1472939
• Product Code: JWH
• UDI-Device Identifier: 03596010206268
• UDI-Public: 03596010206268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 03/20/2024
• Device Catalogue Number: 71420166
• Device Lot Number: 14BT39095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/30/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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
• Patient Age: 67 YR