MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II OXINIUM FEMORAL SIZE 5 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420152
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a knee replacement on (b)(6) 2015.This had to subsequently be revised because patient was allergic to the bone and stated that the surgeon left a wire inside which did damage to the joint.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical concluded, several attempts have been made to obtain clinical/medical documents to no avail.The requested information of the part composition was provided to the patient by phone.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
Event or Problem Description
It was reported that, after a knee replacement had been performed on (b)(6) 2015 with a genesis ii system, the patient developed an allergy to bone cement that required a revision surgery, which was performed on an undisclosed date.The patient also mentioned that the surgeon left a wire inside, which damaged the joint.The knee replacement was revised to a stryker fusion nail, apparently made of a material the patient is allergic to, so it had to be removed.The patient indicated to be allergic to multiple types of plastics and metals, including nickel.The patient is currently on a wheelchair and is working to find out information about her options at this point.

• Brand Name: GENESIS II OXINIUM FEMORAL SIZE 5 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: robert rust ; 1450 brooks road; memphis, TN
• MDR Report Key: 7437879
• Report Number: 1020279-2018-00770
• Device Sequence Number: 13726265
• Product Code: JWH
• UDI-Device Identifier: 03596010430182
• UDI-Public: 03596010430182
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/27/2024

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: 10/26/2023
• Device Catalogue Number: 71420152
• Device Lot Number: 13KM20310
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 03/22/2018; 12/06/2023; 05/20/2024
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 07/09/2018; 01/05/2024; 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2013
• 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: 71420184 / LOT# 14JM00195.; 71453111 / LOT# 14BM11379.; 71926225 / LOT# 14MM02797.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Female