MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY II BCS KNEE INSERT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNKN01200312

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

Patient Problems Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a tka surgery had been performed on (b)(6) 2017, the patient experienced fever, swelling and an infection.This adverse event was solved by a revision surgery on (b)(6) 2021.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the associated device was not returned for evaluation and the reported event could not be confirmed, therefore, the contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, this case reports the patient experienced fever, swelling and an unspecified infection approximately 4 years after a tka.The patient s current health status is unknown and no additional information was provided.Without the requested clinically relevant information, the root cause of the reported symptoms and infection cannot be definitively concluded.The patient impact beyond the reported symptoms and revision cannot be determined and no further medical assessment could be rendered at this time.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 are 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 JOURNEY II BCS KNEE INSERT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13111545
• MDR Text Key: 282917162
• Report Number: 1020279-2021-08951
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1