MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NON-MOD CEM C/R FEM SZ3 LT; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71420068
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision was performed due to periprosthetic infection of the left knee.Three components were explanted.
Additional Manufacturer Narrative
Additional info: results of investigation: it was reported that revision was performed due to periprosthetic infection of the left knee.Three components were explanted.The affected genesis ii articular insert, genesis ii tibial baseplate and genesis ii non-modular cr femoral component, used in treatment, were not returned for evaluation.Therefore, a product analysis could not 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.The devices were sterilized according to sterilization release documentation from quality control.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 event could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.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 device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII NON-MOD CEM C/R FEM SZ3 LT
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9566754
• Report Number: 1020279-2020-00172
• Device Sequence Number: 16869420
• Product Code: JWH
• UDI-Device Identifier: 03596010205780
• UDI-Public: 03596010205780
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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 Expiration Date: 07/20/2025
• Device Model Number: 71420068
• Device Catalogue Number: 71420068
• Device Lot Number: 15GM14600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: PN:71420164, GENESIS II TIBIAL, LOT:E1512119.; PN:71420490 GENESIS II INSERT, LOT:15ET54795.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR