MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420568
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision of bioconvex patella implant.Primary surgery 2017.Progressive lucent line on imaging.
Additional Manufacturer Narrative
The associated genesis ii biconvex patella was returned and evaluated.Examination of the patellar component was performed visually and using optical microscopy.A lab analysis conducted during this investigation indicated that material wear and deformation are observed on the articular surface and around the periphery of the device.Very little bone cement is observed within groove.Peg is intact with minor scratches.The explanted patellar imaging wire shows some discoloration.Based on the information provided, the exact cause of the reported periprosthetic fracture and subsequent revision surgery could not be determined.No material or manufacturing deviations were observed in the course of this investigation.The device was manufactured in 2016.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that 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 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.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7931877
• Report Number: 1020279-2018-02073
• Device Sequence Number: 19262945
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 71420568
• Device Lot Number: 16JM02019
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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