MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 18MM X 160MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71424051
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had occasional clicking and popping while walking.Doctor suggested a constrained knee revision and synovectomy since implants appear to be well fixed and aligned but there are some subtle radiolucencies around cementless stems.A constrained polyethylene available was requested by the doctor for the revision surgery and potentially revision implants, although unlikely to be needed.Information about revision surgery hasn't been received.
Additional Manufacturer Narrative
The associated legion pressfit stems and genesis ii ps insert were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the insert and the femoral component did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that the reported pre-revision events are 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.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: LGN PRESSFIT STEM 18MM X 160MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8036269
• Report Number: 1020279-2018-02369
• Device Sequence Number: 1525607
• Product Code: JWH
• UDI-Device Identifier: 03596010546821
• UDI-Public: 03596010546821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 05/29/2026
• Device Catalogue Number: 71424051
• Device Lot Number: 16CAB0027A
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/03/2018
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421807/14AM11430.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR