MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLFEMOROTIBIAL, SMI-CNSTRINED, CMNTD, PLYMR/MTAL/PLYMR

Catalog Number	71420134
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a primary tka was performed on (b)(6) 2013.On (b)(6) 2019 the femoral component was broken.And a revision surgery was required to removed the broken device.Implants were removed on (b)(6) 2019.The patient has recovered.
Additional Manufacturer Narrative
It was reported that a revision surgery was required due to a broken femoral component.The affected genesis ii oxinium femoral component along with the base plate, patellar component and high flexion insert were returned and evaluated.A lab analysis conducted during this investigation noted that this examination showed fracture of the medial condylar region of the femoral component.The likely fracture initiation location was at or near the articulating surface near the midline of the component.Signs of wear, deformation, and deep scratching was observed on the insert and the patella component likely due to contact with the fractured regions of the femoral component.The cause of the fractured medial condylar region of the femoral component could not be determined from the investigation of the device.The components were not sectioned, which would allow for a more detailed analyses, possibly providing additional information of the fracture initiation region.Such testing, however, is destructive in nature and was not conducted at this time.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.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 could not be corroborated.A clinical analysis noted that the x-ray provided confirms the breakage and shows radiolucency around the femoral component which could be associated with some motion of the component but it is possible this could have been a result of the break instead of prior.Per e-mail communication, ¿doctor doubts there was fault the device.¿ no further investigation is warranted for this complaint.

• Brand Name: GII OXINIUM FEM SIZE 4 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLFEMOROTIBIAL, SMI-CNSTRINED, CMNTD, PLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah ; smith & nephew, inc.; 1450 brooks road; memphis, TN 38116 ; 04479400382
• MDR Report Key: 9209793
• Report Number: 1020279-2019-03676
• Device Sequence Number: 2951155
• Product Code: JWH
• UDI-Device Identifier: 03596010430144
• UDI-Public: 03596010430144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Literature,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2023

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: 03/03/2023
• Device Catalogue Number: 71420134
• Device Lot Number: 13CM02770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 11/21/2023
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/05/2019; 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420166/13HT33739.; 71420574/13DM09649.; 71453111/13FM12357.; 71420166/13HT33739; 71420574/13DM09649; 71453111/13FM12357
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male