MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY / JOURNEY II KNEE IMPL; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Catalog Number UNKN01200301

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924); Joint Dislocation (2374)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka performed on an unspecified date, the patient sustained multiple dislocations, in this event he fell over.A revision surgery was conducted on (b)(6) 2022.During this procedure, the insert peg of an unspecified journey i insert was encountered fractured.The patient's current health status is good post op.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the insert broke.The clinical/medical investigation concluded that, based on the x-ray images we are unable to determine the root cause of the broken insert post.However, the reported multiple dislocations, the reported fall, as well as the patient¿s history of unnatural geometries of his affected leg could not be ruled out as contributory factors.According to the report, the associated devices were not returned for evaluation.According to the updated information provided, the implantation date of 28th november 2012 is arbitrary.The actual date is unknown, however, journey 1 was used at broadgreen from 2010-2013 and 247 primary cases were performed.As a result, that date is proposed as it was exactly 10 years ago and provides a general idea of when it was performed.Additionally, the part and batch number were not provided for review.Although it should be noted the implants remained insitu for approximately 10 years prior to the revision.The patient impact was the reported dislocations, the reported fall, and the subsequent revision.Since, the patient's post-operative health status was reported as good, no further clinical/medical assessment is warranted at this time.Device specific identifiers were not provided thus an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and product prints review could not be performed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.Based on this investigation, the need for corrective action is not indicated.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.Internal complaint reference number: case-2022-00132189-1.

• Brand Name: UNKN JOURNEY / JOURNEY II KNEE IMPL
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 16038651
• MDR Text Key: 306041828
• Report Number: 1020279-2022-05017
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• 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
• Patient Outcome(s): Required Intervention