MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN PROFIX TOTAL KNEE TIB INSERT; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number UNKN01200618

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/22/2021

Event Type  Injury  

Event Description

It was reported that, after a tka surgery, the patient experienced an infection.It is unknown when the implant was performed.This adverse event led to a revision surgery performed on (b)(6) 2021, in which an unkn profix total knee tib insert was explanted.The current health status of patient is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it is noted within the attachments, no clinical/medical documentation is available.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint or determine the root cause of the reported infection.Therefore, the impact to the patient beyond that which has already be reported cannot be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN PROFIX TOTAL KNEE TIB INSERT
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12164318
• MDR Text Key: 261442447
• Report Number: 1020279-2021-05929
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200618
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention