MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNSII CON INS SZ3-4 11MM; PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER

Model Number	71420524
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical/medical team noted: it was reported that a lgn/gii knee was revised 2 days post implantation due to instability and the intra-op finding/realization that a hinged knee would be required.It was communicated that all primary components were revised except for the patellar component and the ¿surgeon did not blame implant¿.No clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.The root cause and patient impact beyond the reported instability and revision could not be concluded as the patient status remains unknown; however, the surgeon reportedly did not fault the implants.Should relevant medical documentation become available, the clinical/medical task may be re-evaluated.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNSII CON INS SZ3-4 11MM
• Common Device Name: PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9713248
• Report Number: 1020279-2020-00554
• Device Sequence Number: 2512969
• Product Code: JWH
• UDI-Device Identifier: 03596010208040
• UDI-Public: 03596010208040
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 71420524
• Device Catalogue Number: 71420524
• Device Lot Number: 19GM13519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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