MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420568
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to pain, loosening of tibial component, malalignment and patellar clunk syndrome.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, without analysis of the explanted components, the root cause of the tibial component loosening cannot be concluded.However, the reported pre-revision events are all most likely related to the early report of mild tilting of the smaller tibial tray, lateral patellar tracking coupled with the early onset of symptoms suggesting residual instability post primary implantation and concerns of the varus alignment.Delayed revision potentially contributed to the severity of the patient¿s worsening symptoms.The patient impact was the persistent anterior knee pain and other reported progressive symptoms in addition to the 1st revision surgery and an expected 2nd revision with a brief post-operative rehabilitative phase.Due to the recurrence of ¿symptomatic scar tissue formation ¿ with a flexion instability post-1st revision, future similar concerns cannot be definitively excluded.No further medical assessment can be rendered 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 part revealed no prior complaints for the listed batch/failure mode.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: GNS II BICONVEX PAT 26MM
• 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: 7979478
• Report Number: 1020279-2018-02224
• Device Sequence Number: 19177298
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2019

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: 08/18/2023
• Device Catalogue Number: 71420568
• Device Lot Number: 13HM14325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/05/2018; 10/05/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/18/2018; 04/02/2019
• 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: Other; Required Intervention
• Patient Age: 67 YR