MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 6; PROS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONS, CEMEN, POLY/METAL/POLY

Model Number	71421116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, the patient had a bilateral tkr performed.Recently patient presented with pain and infection on his right side tkr.A revision surgery was performed on (b)(6) 2020 to correct the issue.All the implants were removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to the patient presented with pain and infection on his right side tkr.The affected genesis ii resurfacting patella, genesis ii tibial baseplate, genesis ii oxinium femoral component and legion xlpe high flexion tibial insert, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.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.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products 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.Review of the risk management files identified the reported failure as potential adverse events.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no medical records provided, our investigation of this report is inconclusive.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.We consider this investigation closed.

• Brand Name: GII OXIN P/S FEM RIGHT SZ 6
• Common Device Name: PROS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONS, CEMEN, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9991960
• Report Number: 1020279-2020-01366
• Device Sequence Number: 3700036
• Product Code: JWH
• UDI-Device Identifier: 03596010469304
• UDI-Public: 03596010469304
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2020

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: 04/01/2025
• Device Model Number: 71421116
• Device Catalogue Number: 71421116
• Device Lot Number: 15AM04221G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 06/27/2020
• 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