MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S5-6 9M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71421542
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the patient fell, he reopened the surgical scar, which was treated with a covering and became infected.He underwent further surgery to debride infected tissue, inspected and wash out to the joint and replaced the poly insert.The tibial and femoral components were examined and found to be intact and well adhered.No operative reports are available.
Additional Manufacturer Narrative
It was reported that the patient reopened the surgical scar when he fell, which became infected.The affected genesis ii cr deep flexion insert, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a 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 or adverse event could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.The fact that the surgical scar was reopened after the fall could be determined as the root cause of the infection.Review of the instructions for use and the risk management files identified the reported failure as potential adverse events.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII CR DEEP FLEX ISRT S5-6 9M
• 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: 9414240
• Report Number: 1020279-2019-04288
• Device Sequence Number: 19830338
• Product Code: JWH
• UDI-Device Identifier: 03596010512475
• UDI-Public: 03596010512475
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 71421542
• Device Catalogue Number: 71421542
• Device Lot Number: 18BM00110
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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