MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ3-4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	71420526
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.
Additional Manufacturer Narrative
The associated legion ps femoral component, genesis ii insert and genesis ii cmt tibial baseplate were not returned for evaluation.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.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical analysis noted no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.No further investigation is warranted for this complaint; however, we 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 SZ3-4 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8102414
• Report Number: 1020279-2018-02588
• Device Sequence Number: 19265880
• Product Code: JWH
• UDI-Device Identifier: 03596010208057
• UDI-Public: 03596010208057
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2024
• Device Catalogue Number: 71420526
• Device Lot Number: D1408411
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR