MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS UNI FEMORAL LARGE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	725004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due breakage of the femoral component.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis conducted during this investigation showed complete fracture and additional cracking on the articulating surface of the femoral.The fractured surface was further analyzed by placing the specimen into the sem which showed that the fracture propagated on the articulating side of the femoral flange.It also showed extreme wear on the tibial insert which could have caused by the leading edge of the fractured surface.The baseplate contained remnants of bone cement which could indicate that the tray was well fixed to the host bone.A visual analysis of the baseplate showed scratches which were likely caused during explantation.The causes of the femoral fracture could not be determined at this time.A review of manufacturing records which 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.There is no information that would suggest the implanted devices failed to meet specifications.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 devices and the reported incident or adverse event could not be corroborated.Batch number for the insert could not be identified as it was illegible on the part.A clinical evaluation noted that the x-rays provided do not show the broken femoral component but there is radiolucency under the posterior surface which could indicate poor bony support under the implant.Based on the limited information provided, the root cause of the reported fracture femoral cannot be confirmed.The future impact to the patient beyond the revision cannot be determined.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GENESIS UNI FEMORAL LARGE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8504798
• Report Number: 1020279-2019-01507
• Device Sequence Number: 16604281
• Product Code: HSX
• UDI-Device Identifier: 03596010256805
• UDI-Public: 03596010256805
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K912735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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 Expiration Date: 05/19/2022
• Device Catalogue Number: 725004
• Device Lot Number: 12EM12772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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