MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420186
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was reported due to instability and pain.The femoral component, the baseplate and the insert were replaced.
Additional Manufacturer Narrative
It was reported that a revision surgery was reported due to instability and pain.The associated genesis ii ps high flexion insert, genesis ii cemented tibial base plate and legion ps femoral component, used in treatment, were not returned.Thus, no product analysis could be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A 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 could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A review of instructions for use revealed the alleged failure is previously identified in the potential adverse events.Per our risk assessment, possible causes could include but not limited to device alignment, or joint laxity.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved and no patient records available, 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 needed.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: GNS II CMT TIB SIZE 5 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9137588
• Report Number: 1020279-2019-03516
• Device Sequence Number: 3186052
• Product Code: JWH
• UDI-Device Identifier: 03596010206350
• UDI-Public: 03596010206350
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/01/2020

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 Model Number: 71420186
• Device Catalogue Number: 71420186
• Device Lot Number: 12CT15966
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 02/01/2020
• 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