MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY INSTR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number UNKN JOURNEY INSTR

Device Problems Failure to Disinfect (1175); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348); Swelling/ Edema (4577)

Event Date 01/01/1900

Event Type  Injury  

Event Description

It was reported that during an investigation study of journey ii and legion implants conducted by hospital/doctor and not sponsored by s&n, 14 of 57 surgeries present a complaint (one surgery per patient).The complications were swelling, pain and infection.13 of the complaints were from journey ii patients and 1 of the complaints was from a legion patient.The hospital is blaming the sterilization process of cutting blocks.No further information is available at the moment.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, 14 patients (13 jii and 1 lgn) experienced complications such as swelling, pain and infection post primary implantation and ¿the hospital is blaming the sterilization process of cutting blocks¿.No patient specific details or further information has been provided for inclusion in a medical investigation.It is unknown if the s+n instructions for use is being followed.The ¿instructions for care, maintenance, cleaning and sterilization indicates ¿the user¿ must ¿validate their sterilization equipment to ensure that the recommended parameters are achieved¿.Based on the limited information provided, the root cause of the reported (common) post-operative symptoms could not be definitively concluded.The sterilization process, however, could not be ruled out as a possible contributing factor.The patient impact beyond the reported events could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available, the medical investigation task may be re-evaluated.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.The contribution of the device to the reported event could not be corroborated.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 INSTR
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: sarah freestone ; brooks road 1450; memphis, TN 38116
• MDR Report Key: 10160537
• MDR Text Key: 195370127
• Report Number: 1020279-2020-02439
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

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 Model Number: UNKN JOURNEY INSTR
• Device Catalogue Number: UNKN01400108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention