MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ 3-4 18MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420530
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery and a washout was performed on knee due to infection.Insert was removed.
Additional Manufacturer Narrative
The associated genesis ii constrained articular insert was not returned for evaluation.Therefore a product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, device history record and sterilization documentation review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.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.

• Brand Name: GNS II CON INS SZ 3-4 18MM
• 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: 8626423
• Report Number: 1020279-2019-01986
• Device Sequence Number: 13995484
• Product Code: JWH
• UDI-Device Identifier: 03596010208071
• UDI-Public: 03596010208071
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Catalogue Number: 71420530
• Initial Date Received by Manufacturer: 04/27/2019
• Supplement Date Received by Manufacturer: 04/27/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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