MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 29MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420570
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a biconvex patella was revised at 5 years for gross loosening.No known cause.Revised to inlay 3 peg patella.No more information provided yet.
Additional Manufacturer Narrative
It was reported that a biconvex patella was revised at 5 years for gross loosening.The affected genesis ii biconvex patellar component was returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were observed on the articulating surface of the device.Damage and deformation were observed on the edges of the non-articulating surface of the patella.The peg appears to be slightly damaged and cement remained attached to the part.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 relationship, if any, between the device and the reported incident could not be corroborated at this time.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation warranted for this complaint; however smith and nephew 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 BICONVEX PAT 29MM
• 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: 8787558
• Report Number: 1020279-2019-02664
• Device Sequence Number: 16561039
• Product Code: JWH
• UDI-Device Identifier: 03596010208279
• UDI-Public: 03596010208279
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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 Expiration Date: 01/12/2024
• Device Model Number: 71420570
• Device Catalogue Number: 71420570
• Device Lot Number: 14AM10376
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 07/14/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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