MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	71420182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to an infection.All the components were removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to an infection.The affected complaint devices, 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 was performed and it 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 incident could not be corroborated.Review of the ifu and risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Infection can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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 additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9991677
• Report Number: 1020279-2020-01365
• Device Sequence Number: 17068729
• Product Code: JWH
• UDI-Device Identifier: 03596010206336
• UDI-Public: 03596010206336
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 71420182
• Device Catalogue Number: 71420182
• Device Lot Number: H1803470
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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