MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ 3-4 15MM; PRSTHSSKNEEPTLLOFMROTIBLSMICNSTRANDCMNTDPLYMRMTALPLYMR

Model Number	71420528
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2019, due to infection.Washout performed, exchange of insert for one of the same size.
Additional Manufacturer Narrative
Additional information: d4, e4, g3, g5 and h4.It was reported that a revision surgery was performed due to infection.Washout was performed, and an exchange of insert for one of the same size was done.The affected genesis ii constrained articular insert, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.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.No medical documents were received for investigation.No further medical assessment can be performed at this time.Review of the instructions for use and the risk management files identified the reported failure as potential adverse events.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GNS II CON INS SZ 3-4 15MM
• Common Device Name: PRSTHSSKNEEPTLLOFMROTIBLSMICNSTRANDCMNTDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9440583
• Report Number: 1020279-2019-04336
• Device Sequence Number: 16762716
• Product Code: JWH
• UDI-Device Identifier: 03596010208064
• UDI-Public: 03596010208064
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 71420528
• Device Catalogue Number: 71420528
• Device Lot Number: 16MM08469
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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