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	10/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed for a biconvex patella component that got a gross loosening.Revised to inlay resurfacing patella on (b)(6) 2019.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to a gross loosening.The associated genesis ii biconvex patellar component, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were observed on the articulating surface of the patella.The returned device has cement present on the inferior surface and the peg is missing.A clinical analysis noted that no medical records were provided.Thus no medical assessment can be performed at this time and the future impact to the patient cannot be determined.The 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.Possible causes could include but not limited to traumatic injury, abnormal motion over time or size of the device used.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.No further investigation is 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: 9281456
• Report Number: 1020279-2019-03894
• Device Sequence Number: 410526
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 02/01/2026
• Device Model Number: 71420570
• Device Catalogue Number: 71420570
• Device Lot Number: 16AM01951
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 03/08/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 03/13/2020
• 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